Identity
- Trade Name
- Skywalker EUDAMED
- Device Name
- Disposables (Marker) EUDAMED
- Model / Reference
- TA8200, TA8300 EUDAMED21411302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973422560978 EUDAMED
- Basic UDI-DI
- 697342256OSR1100IsH6 EUDAMED
- Direct Marketing DI
- 06973422560978 EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I 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
Skywalker by MicroPort NaviBot (Suzhou) Co., Ltd. — Class I — 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 | 697342256OSR1100IsH6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MicroPort NaviBot (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000018412
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED fdf93998-042f-4fcf-8f20-e5982e39f2b5 61 fields · synced Jun 18, 2026