Handpiece Affinity GJS-WC
EUDAMEDFDA UDIClass I (EU MDR)
by Tavger ltd
Identity
- Trade Name
- Handpiece Affinity GJS-WC EUDAMEDHandpiece Affinity G.J.S FDA UDI
- Generic Name
- Surgical irrigation system nozzle FDA UDI
- Device Name
- Disposable Handpiece Affinity G.J.S FDA UDI
- Model / Reference
- The Affinity GJS - Micro Jets Tissue Treatment devices EUDAMEDFG00022 EUDAMEDFDA UDI
- Description
- Disposable Handpiece Affinity G.J.S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017249070 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290017249GJS7G EUDAMED
- FDA Product Code
- FQH FDA UDI
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
- GMDN Term
- Surgical irrigation system nozzle FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Endoscopic spray catheter, single-use
Handpiece Affinity GJS-WC by Tavger Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290017249GJS7G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tavger ltd
- EUDAMED SRN
- IL-MF-000039039
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 30e86361-7c5f-4d9f-81b0-23d7808e8f28 61 fields · synced Jul 23, 2026
- FDA UDI 8a18a734-a591-4e9a-bc2a-cc998a550524 33 fields · synced May 30, 2026