Identity
- Trade Name
- Metafer EUDAMEDFDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- Metafer EUDAMED
- Model / Reference
- 4.4 EUDAMEDMetafer EUDAMEDMicroscopic image acquisition FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250406460007 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504064METAFERF5 EUDAMED
- FDA Product Code
- IBK FDA UDI
- EMDN Code
- W02079092 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3600 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Metafer by MetaSystems Hard & Software GmbH — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 42504064METAFERF5 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- MetaSystems Hard & Software GmbH
- EUDAMED SRN
- DE-MF-000016548
Sources (2)
- EUDAMED 350ab2e5-2e19-4e7a-a83e-5b7378230e3c 61 fields · synced Jun 18, 2026
- FDA UDI 1069ee87-7754-46aa-a0dd-61b15da10aa2 32 fields · synced May 30, 2026