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Robotic-guided Orthopedic Surgical System
EUDAMEDClass IIb (EU MDR)
Ref TiRobot ForcePro Superior
Identity
- Trade Name
- Robotic-guided Orthopedic Surgical System EUDAMED
- Device Name
- Robotic-guided Orthopedic Surgical System EUDAMED
- Model / Reference
- TiRobot ForcePro Superior EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971517000156 EUDAMED
- Basic UDI-DI
- 697151700015FT EUDAMED
- Direct Marketing DI
- 06971517000156 EUDAMED
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Robotic-guided Orthopedic Surgical System by TINAVI Medical Technologies Co., Ltd. — Class IIb — 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 | 697151700015FT | Class IIb | 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 8032a548-e5d5-4e10-bfd4-61dcb868e261 61 fields · synced Jul 18, 2026