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Toumai
EUDAMEDClass IIa (EU MDR)
Ref 12300054Model TFSP8529 95 112,TESP8530 11 107,TFLP8531 95 143,TELP8532 11 138,TFSPN8533 95 112,TFLPN8534 95 143,TFSNO8537,TFLNO8538,TESNO8541,TELNO8542
Identity
- Trade Name
- Toumai EUDAMED
- Device Name
- Trocar Cannula,Trocar Puncture Needle EUDAMED
- Model / Reference
- TFSP8529 95 112,TESP8530 11 107,TFLP8531 95 143,TELP8532 11 138,TFSPN8533 95 112,TFLPN8534 95 143,TFSNO8537,TFLNO8538,TESNO8541,TELNO8542 EUDAMED12300054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971621541347 EUDAMED
- Basic UDI-DI
- 6971621543J0026A8XU EUDAMED
- EMDN Code
- L031299 SURGICAL TROCAR, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 IIa — 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 | 6971621543J0026A8XU | Class IIa | 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 d8d80b6f-7b2b-45c0-ad2f-898362039b6e 61 fields · synced Jun 18, 2026