Identity
- Trade Name
- SkyWalker EUDAMED
- Device Name
- Disposables (Marker) EUDAMED
- Model / Reference
- TA8200, TA8300 EUDAMED21411102 EUDAMED21411202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973422560244 EUDAMED06973422560961 EUDAMED
- Basic UDI-DI
- 697342256OSR1100IsH6 EUDAMED
- Direct Marketing DI
- 06973422560244 EUDAMED06973422560961 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 |
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Manufacturer
- Manufacturer
- MicroPort NaviBot (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000018412
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (2)
- EUDAMED 11af7f6c-b86e-41f8-af45-6d652674f9e4 61 fields · synced Jul 22, 2026
- EUDAMED 7b9f5a23-f510-452e-97c0-1237dee156af 61 fields · synced May 16, 2026