Identity
- Device Name
- Pressure Infusion Bags EUDAMED
- Model / Reference
- GC191821 EUDAMEDGC/CE-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974500610742 EUDAMED
- Basic UDI-DI
- 697450061F01SU05066YK EUDAMED
- EMDN Code
- A088001 PRESSURE INFUSION CUFFS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pressure Infusion Bags by Gcmedica Enterprise Ltd.(wuxi) — Class I — 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 | 697450061F01SU05066YK | Class I | Active |
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Manufacturer
- Manufacturer
- Gcmedica Enterprise Ltd.(wuxi)
- EUDAMED SRN
- CN-MF-000008756
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED becc55d7-1392-4bcf-a86b-2bf85b7a8399 61 fields · synced Jun 19, 2026