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Toumai
EUDAMEDClass IIa (EU MDR)
Ref 12300035Model EL824/30°,EL824/0°,ELW824/30°
Identity
- Trade Name
- Toumai EUDAMED
- Device Name
- 3D Electronic Endoscope EUDAMED
- Model / Reference
- EL824/30°,EL824/0°,ELW824/30° EUDAMED12300035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971621541118 EUDAMED
- Basic UDI-DI
- 6971621543J0026A5XN EUDAMED
- Direct Marketing DI
- 06971621541118 EUDAMED
- EMDN Code
- Z12029009 LAPAROSCOPES 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 — CE/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 | 6971621543J0026A5XN | 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 011ac860-601c-4592-8363-099745d281d0 61 fields · synced Oct 6, 2026