← Back to catalogue
Affinity GJS-WC with accessories
EUDAMEDFDA UDIClass I (EU MDR)
Ref FG00016Model The Affinity GJS - Micro Jets Tissue Treatment devices
by Tavger ltd
Identity
- Trade Name
- Affinity GJS-WC with accessories EUDAMEDAffinity Home with accessories FDA UDI
- Generic Name
- Surgical/orthopaedic lavage control unit FDA UDI
- Device Name
- Affinity G.J.S with accessories MP FDA UDI
- Model / Reference
- The Affinity GJS - Micro Jets Tissue Treatment devices EUDAMEDFG00016 EUDAMEDFDA UDI
- Description
- Affinity G.J.S with accessories MP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017249063 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290017249GJS7G EUDAMED
- FDA Product Code
- FQH FDA UDI
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
- GMDN Term
- Surgical/orthopaedic lavage control unit 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Affinity GJS-WC with accessories by Tavger Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tavger ltd
- EUDAMED SRN
- IL-MF-000039039
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 17760183-e6cc-4eda-94f7-3d9826b6bc6b 61 fields · synced Jul 8, 2026
- FDA UDI fc6c8adb-6b6e-4b8e-85ff-3f15ae5278ed 33 fields · synced May 25, 2026