Identity
- Trade Name
- Syringe Pump EUDAMED
- Device Name
- Syringe Pump EUDAMED
- Model / Reference
- M800-L EUDAMEDM800A-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429024654 EUDAMED
- Basic UDI-DI
- 69454290SP003R4 EUDAMED
- Direct Marketing DI
- 06945429024654 EUDAMED
- EMDN Code
- Z12030302 SYRINGE PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Syringe Pump by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — 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 | 69454290SP003R4 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 4ec83f9b-5940-430b-b9d1-01fbd9fb3cdf 61 fields · synced Jun 18, 2026