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Handpiese Affinity GJS-Mini
EUDAMEDClass I (EU MDR)
Ref FG00027Model The Affinity GJS - Micro Jets Tissue Treatment devices
by Tavger ltd
Identity
- Trade Name
- Handpiese Affinity GJS-Mini EUDAMED
- Model / Reference
- The Affinity GJS - Micro Jets Tissue Treatment devices EUDAMEDFG00027 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290017249148 EUDAMED
- Basic UDI-DI
- 7290017249GJS7G EUDAMED
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Endoscopic spray catheter, single-use
Handpiese Affinity GJS-Mini by Tavger Ltd — 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 | 7290017249GJS7G | Class I | Active |
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Manufacturer
- Manufacturer
- Tavger ltd
- EUDAMED SRN
- IL-MF-000039039
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 7215dd10-320b-4165-891c-e50162848ae8 61 fields · synced Jul 26, 2026