Identity
- Trade Name
- Navigation Tool Kit EUDAMED
- Device Name
- Navigation Tool Kit EUDAMED
- Model / Reference
- Tikit-A500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971517000330 EUDAMED
- Basic UDI-DI
- 697151700016FV EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Neurological stereotactic surgery system
Navigation Tool Kit by TINAVI Medical Technologies Co., Ltd. — Class IIa — 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 | 697151700016FV | 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 7b1b3b61-3533-4cdf-9d2a-a58970c5aace 61 fields · synced Jun 18, 2026