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NEFA Standard
EUDAMEDClass B (EU MDR)
Ref 991-91791Model 994-91801, 990-91901, 991-91791
Identity
- Trade Name
- NEFA Standard EUDAMED
- Device Name
- NEFA-HR(2) R1 Set, NEFA-HR(2) R2 Set, NEFA Standard EUDAMED
- Model / Reference
- 994-91801, 990-91901, 991-91791 EUDAMED991-91791 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987481165110 EUDAMED
- Basic UDI-DI
- 49874814987481165120TX EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
NEFA Standard by Fujifilm Wako Pure Chemical Corporation — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 49874814987481165120TX | Class B | Active |
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Manufacturer
- Manufacturer
- FUJIFILM Wako Pure Chemical Corporation
- EUDAMED SRN
- JP-MF-000013944
- Authorised Representative
- FUJIFILM Wako Chemicals Europe GmbH DE-AR-000011552
Sources (1)
- EUDAMED b14e7253-f722-435f-87e1-f2231e733847 61 fields · synced May 22, 2026