← Back to catalogue
GMkey
EUDAMEDClass III (EU MDR)
Ref GMC-3820-SRef GMH-21420-S-WRef GMH-31220-SRef GMC-48515-SRef GMH-21220-SRef GMC-2820-SRef GMC-2720-SRef GMC-3720-SRef GMC-11416-SRef GMH-21216-S-WRef GMC-3715-SRef GMC-2715-SRef GMH-21420-SRef GMC-2716-SRef GMC-11620-S
Identity
- Trade Name
- GMkey EUDAMED
- Device Name
- Central Venous Catheter Kits EUDAMEDHemodialysis Catheter Kits EUDAMED
- Model / Reference
- GMC-3820-S EUDAMEDGMH-21420-S-W EUDAMEDGMH-31220-S EUDAMEDGMC-48515-S EUDAMEDGMH-21220-S EUDAMEDGMC-2820-S EUDAMEDGMC-2720-S EUDAMEDGMC-3720-S EUDAMEDGMC-11416-S EUDAMEDGMH-21216-S-W EUDAMEDGMC-3715-S EUDAMEDGMC-2715-S EUDAMEDGMH-21420-S EUDAMEDGMC-2716-S EUDAMEDGMC-11620-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957314804494 EUDAMED06957314811843 EUDAMED06957314803107 EUDAMED06957314802841 EUDAMED06957314806023 EUDAMED06957314803602 EUDAMED06957314802148 EUDAMED06957314802155 EUDAMED06957314802629 EUDAMED06957314811683 EUDAMED06957314802278 EUDAMED06957314802254 EUDAMED06957314806511 EUDAMED06957314802261 EUDAMED06957314802162 EUDAMED
- Basic UDI-DI
- B-06957314804494 EUDAMEDB-06957314811843 EUDAMEDB-06957314803107 EUDAMEDB-06957314802841 EUDAMEDB-06957314806023 EUDAMEDB-06957314803602 EUDAMEDB-06957314802148 EUDAMEDB-06957314802155 EUDAMEDB-06957314802629 EUDAMEDB-06957314811683 EUDAMEDB-06957314802278 EUDAMEDB-06957314802254 EUDAMEDB-06957314806511 EUDAMEDB-06957314802261 EUDAMEDB-06957314802162 EUDAMED
- EMDN Code
- C01020203 CENTRAL VENOUS MULTI-LUMEN (>2) CATHETERS, NON-TUNNELED EUDAMEDF900201 TEMPORARY HEMODIALYSIS CATHETERS AND KITS EUDAMEDC01020202 CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED EUDAMEDC01020201 CENTRAL I.V. SINGLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass 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
Category: Central venous catheterization kit, short-term
GMkey by Giant Medical Equipment (Guangzhou) Co., Ltd. — Class III — MDD — 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-06957314804494 | 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 (15)
- EUDAMED fc7d0774-5593-4a74-9953-45ed8ee4a91a 61 fields · synced Sep 17, 2026
- EUDAMED 4c4df988-cc9e-4030-9e75-02918cb6b416 61 fields · synced May 16, 2026
- EUDAMED 6590be5c-12d4-4daf-a9b1-e8f2eb7ce6b7 61 fields · synced May 16, 2026
- EUDAMED 246299b5-98be-4dce-906c-c9470d7c2242 61 fields · synced May 16, 2026
- EUDAMED e8f945aa-12bb-49d8-909e-c2b593e6b372 61 fields · synced May 17, 2026
- EUDAMED 041ff943-74af-4ffe-83be-3a69d9b5e5ef 61 fields · synced May 17, 2026
- EUDAMED 4dbec6e9-2efa-4ada-8519-6f46e6c01d32 61 fields · synced May 17, 2026
- EUDAMED aabdfa8d-1100-4f07-872c-0a1cd0a3f621 61 fields · synced May 17, 2026
- EUDAMED fbac8086-047e-43e4-a790-87689ffb277f 61 fields · synced May 17, 2026
- EUDAMED e2586da1-9aa9-4b74-b330-49fc67bf72d7 61 fields · synced May 17, 2026
- EUDAMED 090c1526-f094-4ac4-893c-e11d30d930b5 61 fields · synced May 17, 2026
- EUDAMED 8ac84adb-c98e-434a-81cf-ec37c32853fc 61 fields · synced May 17, 2026
- EUDAMED 234f91d1-6227-47ba-9f36-5988ca60d517 61 fields · synced May 18, 2026
- EUDAMED e423289a-9e7d-471c-a643-23c00dea2000 61 fields · synced May 18, 2026
- EUDAMED 3db14882-edcf-4849-bf5a-f1653f2e0895 61 fields · synced May 19, 2026