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Sterile, Disposable Navigation Tool Kits
EUDAMEDClass IIa (EU MDR)
Ref SS1Model TS1，TS2，SS1，SS2Ref TS2Ref TS1
Identity
- Trade Name
- Sterile, Disposable Navigation Tool Kits EUDAMED
- Device Name
- Sterile,Disposable Navigation Tool Kits EUDAMED
- Model / Reference
- TS1，TS2，SS1，SS2 EUDAMEDSS1 EUDAMEDTS2 EUDAMEDTS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971517000286 EUDAMED06971517000279 EUDAMED06971517000262 EUDAMED
- Basic UDI-DI
- 697151700017FX EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa 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
Sterile, Disposable Navigation Tool Kits by TINAVI Medical Technologies Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697151700017FX | Class IIa | Active |
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Manufacturer
- Manufacturer
- TINAVI Medical Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000021467
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 88488267-3f6b-43a0-b45f-a226de345083 61 fields · synced Jul 27, 2026
- EUDAMED 5199382c-ca95-4d72-9449-a438d677dc2d 61 fields · synced May 18, 2026
- EUDAMED 0041d1cc-f58f-4a1e-8a6f-ce39f054fc82 61 fields · synced May 18, 2026