Hettich EBA 200 Centrifuge MD
Centrifuge Hettich EBA 200
Hettich EBA 200
Hettich EBA 200 Centrifuge MD
Centrifuge Hettich EBA 200
Hettich EBA 200

Hettich EBA 200 Centrifuge MD

Hettich EBA 200 MD, type 1810 – Class IIa medical device under MDR (EU) 2017/745. For professional separation of human whole blood or blood components.

  • 8-place E4413 angle rotor, 33°
  • Tubes up to 10 ml*
  • Max. 6,000 RPM / 3,461 RCF
  • CE 0483

* Compatibility depends on tube dimensions and manufacturer specifications.

100347
immediately available
€1,470.00
incl. tax, plus shipping Shipping excluded

 
Class IIa medical device · MDR (EU) 2017/745 · CE 0483

Hettich EBA 200 MD – Class IIa Medical Device

Compact benchtop centrifuge for the professional centrifugation of human blood samples. The version offered here is the medical-device version, type 1810.

1810 MD vs. 1800 – which version is being compared?

Different regulatory versions are sold under the name “EBA 200”. This product page refers to the EBA 200 MD, type 1810.

EBA 200 MD · type 1810
StatusClass IIa medical device
FrameworkMDR (EU) 2017/745
Intended purposeSeparation of human whole blood or blood components
EBA 200 · type 1800
StatusIVD version
FrameworkIVDR (EU) 2017/746
Use contextIn-vitro diagnostics / sample examination
Hettich EBA 200 centrifuge
Hettich EBA 200 – device view. The version offered is the MD version, type 1810.
Not faster – intended for a different regulatory use

Why choose the EBA 200 MD?

The key difference from the EBA 200 type 1800 is not higher centrifuge performance. Both versions reach up to 6,000 RPM and 3,461 RCF. The EBA 200 MD type 1810 is classified as a Class IIa medical device under MDR (EU) 2017/745. Its intended purpose includes separating whole blood or blood components of human origin.

Which workflow is involved?

IVD sample preparation
1Blood or urine sample
2Centrifugation
3In-vitro examination to obtain diagnostic information
EBA 200 type 1800 · IVDR
Medical blood processing
1Human whole blood or blood components
2Centrifugation
3The processed blood components are intended for subsequent implantation or administration into the body
MDR Rule 3: centrifugation → Class IIa

The EBA 200 MD type 1810 is classified as a Class IIa medical device. Its manufacturer-defined intended purpose includes the separation of human whole blood or blood components.

This diagram provides regulatory orientation only and is not a blanket recommendation for use. The intended purpose of the actual device, the instructions for the products used and the real workflow remain decisive.

Typical questions in clinical practice and quality management

“May I use this centrifuge for the workflow?”

RPM, RCF and tube size are not the only relevant factors. The centrifuge's intended purpose should also match the planned workflow.

“Can I document why this device was selected?”

Type 1810, Class IIa, MDR, CE 0483, Basic UDI-DI and manufacturer documentation provide a clear basis for SOPs, equipment registers and internal quality documentation.

“Is the MD technically better?”

Not automatically. Medical-device classification does not demonstrate higher PRP quality or better clinical outcomes. Its value lies in a clearly documented medical intended purpose and regulatory classification.

“When can an MD version be required?”

That depends on the actual workflow and the intended purposes of all products used. For use in Germany, § 4 MPBetreibV requires products to be operated and used according to their intended purpose.

Why Class IIa?

MDR Annex VIII, Rule 3 covers non-invasive devices intended to modify the biological or chemical composition of blood or other body liquids where those liquids are intended for subsequent implantation or administration into the body. Such devices are generally Class IIb. Where the treatment consists of filtration, centrifugation or exchange of gas or heat, classification is Class IIa. The EBA 200 MD type 1810 is classified as a Class IIa medical device.

Important qualification

There is no blanket rule stating that every PRP procedure must be performed specifically with the Hettich EBA 200 MD. The concrete application, the intended purpose of all products used and the manufacturers' instructions remain decisive.

For use in Germany, § 4 MPBetreibV additionally requires products to be operated and used according to their intended purpose.

Legal references: MDR (EU) 2017/745 · Annex VIII · Rule 3 · § 4 MPBetreibV (Germany)

Control logic

RPM · RCF · t RPM RCF TIME

RPM, RCF and run time can be adjusted directly on the device.

Correct loading

2 tubes 4 tubes Incorrect correct correct

Load opposing positions symmetrically. The examples show correct loading with 2 and 4 tubes and one uneven loading pattern.

Regulatory classification

VersionEBA 200 MD
Type1810
ClassificationClass IIa medical device
RegulationMDR (EU) 2017/745
CE markingCE 0483
Basic-UDI-DI040506740100249W
Manufacturer WEEE registration no.DE 92954423

Intended use

According to the manufacturer, the Hettich EBA 200 MD is intended to separate whole blood or blood components of human origin into their constituent parts.

Variable physical parameters can be set within the limits defined by the device. According to the operating instructions, the centrifuge may only be used by appropriately qualified personnel in closed laboratories.

Compact design for smaller sample volumes

With dimensions of 261 × 353 × 228 mm and a weight of approximately 9 kg, the EBA 200 MD requires relatively little bench space. Maximum speed is 6,000 RPM and maximum relative centrifugal force is 3,461 RCF. For the standard E4413 rotor, Hettich currently specifies tubes up to 10 ml; actual compatibility also depends on tube dimensions and manufacturer instructions.

Direct RPM and RCF setting

The EBA 200 MD allows direct selection and setting of RPM or RCF. Run time and additional centrifugation parameters can also be selected via the control panel.

Run time can be set from 1 to 99 minutes and from 1 to 59 seconds. Continuous operation is also possible. The centrifugation radius can be taken into account for RCF-based settings.

8-place E4413 angle rotor

The current Hettich operating instructions list the 8-place E4413 angle rotor for the EBA 200 MD. The rotor has a 33° angle and is specified for a maximum of 50,000 cycles or five years of use.

Permissible dimensions vary depending on the centrifuge tube used. The tube manufacturer's specifications must also be observed.

E4413 rotor of the Hettich EBA 200 MD
E4413 rotor of the Hettich EBA 200 MD – 8-place angle rotor, 33°

Flexible centrifugation settings

In addition to timed centrifugation runs, continuous operation and short-run centrifugation are available. The fast and slow braking levels can be selected for deceleration. Settings are entered via the control panel.

Signals and lid control

An audible signal can be issued at the end of a centrifugation run. It can be activated or deactivated in the device menu and its volume can be adjusted. Automatic lid unlocking after the run can also be configured; unlocking takes place when the rotor is stationary.

Safety functions and installation

The EBA 200 MD features monitored lid locking. For safe operation, Hettich requires a stable, level installation surface. During a centrifugation run, a 300 mm safety zone around the centrifuge must also be maintained; clearance from ventilation slots and openings must likewise be observed.

Correct rotor loading

Balanced loading is essential for safe centrifugation. Opposing tubes should be loaded evenly in accordance with the manufacturer's instructions. The secure seating of the rotor must be checked before each run. Only suitable centrifuge tubes and approved accessories may be used.

Use in connection with PRP

The official intended use of the Hettich EBA 200 MD includes the separation of human whole blood and blood components.

When used as part of a PRP preparation process, the specific centrifugation parameters must be selected according to the instructions for the PRP tube or PRP system being used. There is no universal setting for all PRP tubes. In the current Hettich documentation, PRP is not described as an independent intended use.

Related specialist information

Vi PRP-PRO PRP tubesRCF/RPM calculatorPRP centrifugation: RCF, RPM & time

Technical data

ManufacturerAndreas Hettich GmbH, Tuttlingen
ModelHettich EBA 200 MD
Type1810
Regulatory statusClass IIa medical device
RegulationMDR (EU) 2017/745
CE markingCE 0483
Basic-UDI-DI040506740100249W
Manufacturer WEEE registration no.DE 92954423
Rotor positions8
Standard rotorE4413 angle rotor, 8-place, 33°
Standard tube capacityup to 10 ml*
Maximum speed6,000 RPM
Maximum RCF3,461
Maximum permissible density1.2 kg/dm³
Dimensions (W × D × H)261 × 353 × 228 mm
Weightapprox. 9 kg
Power rating100 VA
Installation siteindoor use
Manufacturer SRNDE-MF-000010680

* For the standard E4413 rotor, Hettich currently specifies tubes up to 10 ml. Actual compatibility also depends on tube dimensions and the tube manufacturer's instructions.

Scope of delivery

According to the Hettich operating instructions, the scope of delivery includes the rotor, power cable, operating instructions, fuse inserts and a hexagon socket key.

Observe manufacturer documentation

The complete operating instructions must be read and observed before first use. The EBA 200 MD may only be operated within its intended use and in accordance with the manufacturer's instructions. The respective manufacturer specifications also apply to accessories and centrifuge tubes.

Features
MAX. CAPACITY: 8 × 10 ml | MAX. RCF: 3,461 × g | MAX. SPEED: 6,000 rpm | WEIGHT: approx. 9 kg | COOLING: Air cooling | DIMENSIONS (W × D × H): 261 × 353 × 228 mm

GPSR - General Product Safety Regulation

GPSR – General Product Safety Regulation

Responsible Economic Operator according to GPSR:

Andreas Hettich GmbH

Föhrenstraße 12

78532 Tuttlingen

Germany

Tel. +49 7461 7050

FAX: +49 7461 705 1125

https://www.hettichlab.com/de/kontakt/

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