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AbbVie ENFit NJ
EUDAMEDClass IIa (EU MDR)
Ref 0AV094-002Model 0AV094
by AbbVie Inc.
Identity
- Trade Name
- AbbVie ENFit NJ EUDAMED
- Device Name
- AbbVie ENFit NJ EUDAMED
- Model / Reference
- 0AV094 EUDAMED0AV094-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054083021850 EUDAMED
- Basic UDI-DI
- 8054083000V0AV094XE EUDAMED
- EMDN Code
- G02020102 NASOJEJUNAL/NASODUODENAL TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AbbVie ENFit NJ by Abbvie Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8054083000V0AV094XE | Class IIa | Active |
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Manufacturer
- Manufacturer
- AbbVie Inc.
- EUDAMED SRN
- US-MF-000014055
- Authorised Representative
- Allergan Pharmaceuticals International Limited IE-AR-000000650
Sources (1)
- EUDAMED 4b443d68-8876-49b7-9aed-6f6b7d24fbe5 61 fields · synced Jul 15, 2026