Identity
- Trade Name
- Leg Positioner EUDAMED
- Device Name
- Surgical Instruments - Knee Kit EUDAMED
- Model / Reference
- 21312102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973422560282 EUDAMED
- Basic UDI-DI
- 697342256OSR1100IrH4 EUDAMED
- Direct Marketing DI
- 06973422560282 EUDAMED
- EMDN Code
- L1399 ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I 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: Robotic surgical forceps, reusable
Leg Positioner by MicroPort NaviBot (Suzhou) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Robotic surgical forceps, reusable.
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- EndoWrist — Intuitive Surgical, Inc. · Class II
- Single-Site — Intuitive Surgical, Inc. · Class II
- Monopolar L-Hook Electrode Ø 5 mm x 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
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 | 697342256OSR1100IrH4 | 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 (1)
- EUDAMED bc5e712f-f888-4467-ac2b-e6e4ab3b20d2 61 fields · synced Jul 20, 2026