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Toumai
EUDAMEDClass I (EU MDR)
Ref 12300040Model IST8544,AST8546,EST8545,EST8563,EST8560,EST8561
Identity
- Trade Name
- Toumai EUDAMED
- Device Name
- Sterilizing Trays EUDAMED
- Model / Reference
- IST8544,AST8546,EST8545,EST8563,EST8560,EST8561 EUDAMED12300040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971621541255 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
Toumai by Shanghai MicroPort MedBot (Group) 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 | 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 2966d87d-70b8-4fa4-8852-24c43d327eaf 61 fields · synced Jun 19, 2026