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Surgical Instrument Holding and Positioning System
EUDAMEDClass I (EU MDR)
Ref NY/SDB-0101
Identity
- Trade Name
- Surgical Instrument Holding and Positioning System EUDAMED
- Device Name
- Surgical Instrument Holding and Positioning System EUDAMED
- Model / Reference
- NY/SDB-0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978544400188 EUDAMED
- Basic UDI-DI
- 697854440SDB0101QA EUDAMED
- Direct Marketing DI
- 06978544400188 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
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Robotic surgical forceps, reusable
Surgical Instrument Holding and Positioning System by Zhejiang Nayun Medical Devices Co., Ltd. — Class I — MDR — listed in EUDAMED
Similar devices
Also classified as Robotic surgical forceps, reusable.
- EndoWrist — Intuitive Surgical, Inc. · Class II
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- Toumai — Shanghai MicroPort MedBot (Group) Co., Ltd. · Class I
- Right Angle Dissector, Long Ø 10 mm x length 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
- 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 | 697854440SDB0101QA | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Nayun Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000047541
- Authorised Representative
- REP Europe GmbH DE-AR-000025090
Sources (1)
- EUDAMED c9f7932f-c2ab-4d29-8e99-59ce4e938ae6 61 fields · synced Jun 18, 2026