Identity
- Trade Name
- GMkey EUDAMED
- Device Name
- Hemodialysis Catheter Kits EUDAMED
- Model / Reference
- GMH-21220-S-W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957314811690 EUDAMED
- Basic UDI-DI
- B-06957314811690 EUDAMED
- EMDN Code
- F900201 TEMPORARY HEMODIALYSIS CATHETERS AND KITS EUDAMED
Classification
- Device Class
- Class IIa 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 IIa — MDD — 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-06957314811690 | Class IIa | 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 989288fb-c992-4dd2-8692-2a0f8504abd8 61 fields · synced Jun 19, 2026