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CR Specific G4
EUDAMEDClass A (EU MDR)
Ref 1N3001G4Model CR Specific G4
by Abd Srl
Identity
- Trade Name
- CR Specific G4 EUDAMED
- Device Name
- Conjugate IgG4 SpE / Coniugato IgG4 SpE EUDAMED
- Model / Reference
- CR Specific G4 EUDAMED1N3001G4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058945155882 EUDAMED
- Basic UDI-DI
- 8058945151N3001G43K EUDAMED
- Direct Marketing DI
- 08058945155882 EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
CR Specific G4 by Abd Srl — Class A — 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 | 8058945151N3001G43K | Class A | Active |
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Manufacturer
- Manufacturer
- Abd Srl
- EUDAMED SRN
- IT-MF-000029729
Sources (1)
- EUDAMED c82b8d5c-c91b-452e-99d8-855333c88076 61 fields · synced Oct 7, 2026