Identity
- Trade Name
- A4-Set No Clamp EUDAMED
- Device Name
- A32BL-Set EUDAMED
- Model / Reference
- Infusion set EUDAMED8400A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060471910234 EUDAMED
- Basic UDI-DI
- 506047191ASPF EUDAMED
- EMDN Code
- A070103 INFUSION TUBING ADAPTERS AND CONNECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern 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
A4-Set No Clamp by Anaesthetic Medical Systems Ltd — 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 | 506047191ASPF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Anaesthetic Medical Systems Ltd
- EUDAMED SRN
- GB-MF-000016544
- Authorised Representative
- MD REPS Ltd XI-AR-000040375
Sources (1)
- EUDAMED 16fcbb0f-2374-463f-9439-1a5af4ebd3e8 61 fields · synced Jun 19, 2026