Identity
- Model / Reference
- MK-FSRA-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060999351298 EUDAMED
- Basic UDI-DI
- 506059088ISOSAFFS8J EUDAMED
- EMDN Code
- G02020201 GASTROSTOMY, TUBES AND SETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gastrostomy tube
Mk-Fsra-12 by GBUK Group — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506059088ISOSAFFS8J | Class I | Active |
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Manufacturer
- Manufacturer
- GBUK Group
- EUDAMED SRN
- GB-MF-000002238
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED 8f12ce2c-f701-458f-a6c6-f6943dd893fd 61 fields · synced Jul 20, 2026