Identity
- Trade Name
- GMkey EUDAMED
- Device Name
- Central Venous Catheter Kits EUDAMED
- Model / Reference
- GMC-11620-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957314802162 EUDAMED
- Basic UDI-DI
- B-06957314802162 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
Category: Central venous catheterization kit, short-term
GMkey by Giant Medical Equipment (Guangzhou) Co., Ltd. — Class III — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Central venous catheterization kit, short-term.
- Acent-1 — Global Medikit Limited · Class III
- Centurion — Centurion Medical Products · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Cook — COOK INCORPORATED · Class II
- Shun Monitor® — Shunmei Medical Co.,Ltd · Class III
- ARROW — TELEFLEX INCORPORATED · Class II
- Medline Industries, Inc. — Centurion Medical Products · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
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-06957314802162 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
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 3db14882-edcf-4849-bf5a-f1653f2e0895 61 fields · synced Oct 6, 2026