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Sterile, Disposable Navigation Tool Kits
EUDAMEDClass IIa (EU MDR)
Ref SS2Model TS1，TS2，SS1，SS2
Identity
- Trade Name
- Sterile, Disposable Navigation Tool Kits EUDAMED
- Device Name
- Sterile,Disposable Navigation Tool Kits EUDAMED
- Model / Reference
- TS1，TS2，SS1，SS2 EUDAMEDSS2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971517000293 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 (1)
- EUDAMED bbf3eea5-b758-4ca5-a2ff-b7eba1eab38e 61 fields · synced Jun 18, 2026