Identity
- Trade Name
- GMkey EUDAMED
- Device Name
- Central Venous Catheter Kits EUDAMED
- Model / Reference
- GMC-11416-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957314802629 EUDAMED
- Basic UDI-DI
- B-06957314802629 EUDAMED
- EMDN Code
- C01020201 CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
GMkey by Giant Medical Equipment (Guangzhou) Co., Ltd. — Class III — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06957314802629 | Class III | Active |
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Manufacturer
- Manufacturer
- Giant Medical Equipment (Guangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000005460
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED fbac8086-047e-43e4-a790-87689ffb277f 61 fields · synced Oct 6, 2026