Identity
- Trade Name
- HAEMATOKRIT 200 - 100-127V/50-60HZ EUDAMEDHAEMATOKRIT 200 FDA UDI
- Generic Name
- Microhaematocrit centrifuge IVD FDA UDI
- Device Name
- HAEMATOKRIT 200 EUDAMEDbench-top centrifuge with rotor FDA UDI
- Model / Reference
- 1801-01 EUDAMEDFDA UDI1801 EUDAMED
- Description
- bench-top centrifuge with rotor FDA UDI
Identifiers
- Catalog Number
- 1801-01 FDA UDI
- Primary DI / UDI-DI
- 04050674092746 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050674092746 EUDAMED
- FDA Product Code
- GKG FDA UDI
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
- GMDN Term
- Microhaematocrit centrifuge IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.6400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microhaematocrit centrifuge IVD
Haematokrit 200 by Andreas Hettich GmbH & Co. KG — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH & Co. KG
Sources (2)
- FDA UDI a594a5df-2f82-4fc0-9d61-0ba99032e40a 34 fields · synced Jun 18, 2026
- EUDAMED 0b92cfc7-ab09-4f4c-8a2f-27a87351bae1 61 fields · synced Jun 18, 2026