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Silicone Gastrostomy Tube
EUDAMEDClass IIb (EU MDR)
Ref GT12FRef GT24FRef GT12F, GT14F, GT16F, GT18F, GT20F, GT22F, GT24FRef GT20F
Identity
- Trade Name
- Silicone Gastrostomy Tube EUDAMED
- Device Name
- Silicone Gastrostomy Tube EUDAMED
- Model / Reference
- GT12F EUDAMEDGT24F EUDAMEDGT12F, GT14F, GT16F, GT18F, GT20F, GT22F, GT24F EUDAMEDGT20F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934415055413 EUDAMED06934415055598 EUDAMEDD-GT8B EUDAMED06934415055574 EUDAMED
- Basic UDI-DI
- B-06934415055413 EUDAMEDB-06934415055598 EUDAMEDB-GT8B EUDAMEDB-06934415055574 EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Silicone Gastrostomy Tube by Beijing ZKSK Technology Co., Ltd — Class IIb — 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-06934415055413 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (5)
- EUDAMED 2d139957-6f7f-4466-b088-286606c39965 61 fields · synced Oct 6, 2026
- EUDAMED c331427a-8511-4323-9666-037465baa28c 61 fields · synced May 18, 2026
- EUDAMED 55c4a027-9f45-454e-b110-8af86628ad66 61 fields · synced May 18, 2026
- EUDAMED 155d71cd-47e0-44ca-a9cc-f7e75e878baf 61 fields · synced May 18, 2026
- EUDAMED 55c4a027-9f45-454e-b110-8af86628ad66-1 61 fields · synced Jun 10, 2026