Identity
- Trade Name
- MIKRO 200R - 100-127V/50-60Hz EUDAMEDMIKRO 200R FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- MIKRO 200 / 200 R EUDAMEDTabletop centrifuge refrigerated FDA UDI
- Model / Reference
- 2400, 2405 EUDAMED2405-01 EUDAMEDMIKRO 200R - 100V-127V/50-60Hz FDA UDI
- Description
- Tabletop centrifuge refrigerated FDA UDI
Identifiers
- Catalog Number
- 2405-01 FDA UDI
- Primary DI / UDI-DI
- 04050674043489 EUDAMEDFDA UDI
- Basic UDI-DI
- 040506740100109K EUDAMED
- Direct Marketing DI
- 04050674043489 EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
- GMDN Term
- General-purpose centrifuge IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 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: General-purpose centrifuge IVD
Mikro 200r by Andreas Hettich GmbH & Co. KG — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose centrifuge IVD.
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH & Co. KG
Sources (2)
- FDA UDI ad050938-3d7c-45bc-a791-cf9399fb28d7 34 fields · synced Jun 11, 2026
- EUDAMED ab81e34e-71d1-4187-81ae-668b78df1651 61 fields · synced Jun 11, 2026