Identity
- Trade Name
- Automated C3d plate EUDAMED
- Device Name
- Automated C3d Plate EUDAMED
- Model / Reference
- 0066260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10888234002413 EUDAMED
- Basic UDI-DI
- 88823401W0103030305C000SN EUDAMED
- EMDN Code
- W0103030305 MONOSPECIFIC ANTIHUMAN SERUM EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
Automated C3d plate by Immucor, Inc. — Class C — 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 | 88823401W0103030305C000SN | Class C | Active |
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Manufacturer
- Manufacturer
- Immucor, Inc.
- EUDAMED SRN
- US-MF-000011568
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (1)
- EUDAMED 69b09de7-91f5-4081-8e79-68f68b60d011 61 fields · synced Jun 18, 2026