Identity
- Trade Name
- Toumai EUDAMED
- Device Name
- Trocar Sealing Cap EUDAMED
- Model / Reference
- ISC8513 ,ESC8514,ISC8524 EUDAMED12400017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971621541412 EUDAMED
- Basic UDI-DI
- 6971621543J0026A9XW EUDAMED
- Unit of Use DI
- 06971621540913 EUDAMED
- EMDN Code
- K01020299 ROBOTIC SURGERY INSTRUMENT, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Toumai by Shanghai MicroPort MedBot (Group) Co., Ltd. — Class I — 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 | 6971621543J0026A9XW | 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 13f0a60a-0959-4bf3-ada4-acbfb41b93be 61 fields · synced Oct 6, 2026