Identity
- Trade Name
- MIKRO 220, 100-127V/50-60Hz EUDAMEDMIKRO 220 FDA UDI
- Generic Name
- Microsample centrifuge IVD FDA UDI
- Device Name
- MIKRO 220 / 220 R EUDAMEDbench-top centrifuge without rotor FDA UDI
- Model / Reference
- 2200-01 EUDAMEDFDA UDI2200, 2205 EUDAMED
- Description
- bench-top centrifuge without rotor FDA UDI
Identifiers
- Catalog Number
- 2200-01 FDA UDI
- Primary DI / UDI-DI
- 04050674040884 EUDAMEDFDA UDI
- Basic UDI-DI
- 040506740100119M EUDAMED
- Direct Marketing DI
- 04050674040884 EUDAMED
- FDA Product Code
- GKG FDA UDI
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
- GMDN Term
- Microsample centrifuge IVD FDA UDI
Classification
- Device Class
- Class A 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
New Device
No
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: Microsample centrifuge IVD
Mikro 220 by Andreas Hettich GmbH & Co. KG — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | 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 7305eb4c-2968-4484-8758-551fdbc77a9e 34 fields · synced Jun 19, 2026
- EUDAMED df862dd6-2765-4acd-b993-d79a916c267a 61 fields · synced Jun 19, 2026