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Toumai
EUDAMEDClass I (EU MDR)
Ref 12300046Model IST8544,AST8546,EST8545,EST8563,EST8560,EST8561
Identity
- Trade Name
- Toumai EUDAMED
- Device Name
- Sterilizing Trays EUDAMED
- Model / Reference
- IST8544,AST8546,EST8545,EST8563,EST8560,EST8561 EUDAMED12300046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971621541262 EUDAMED
- Basic UDI-DI
- 6971621543J0026B2XK EUDAMED
- EMDN Code
- L1399 ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Toumai by Shanghai MicroPort MedBot (Group) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Robotic surgical forceps, reusable.
- EndoWrist — Intuitive Surgical, Inc. · Class II
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- 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
- EndoWrist — Intuitive Surgical, Inc. · Class II
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 | 6971621543J0026B2XK | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai MicroPort MedBot (Group) Co., Ltd.
- EUDAMED SRN
- CN-MF-000022869
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED 8e0afd83-7aa5-4b43-9a67-e7dbba3e75a3 61 fields · synced Jun 18, 2026