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Syringe Pump
EUDAMEDClass IIb (EU MDR)
Ref M800AModel M800Ref M800-TCIRef M200ARef M800-LRef M500BModel M500A
Identity
- Trade Name
- Syringe Pump EUDAMED
- Device Name
- Syringe Pump EUDAMED
- Model / Reference
- M800 EUDAMEDM800A EUDAMEDM800-TCI EUDAMEDM200A EUDAMEDM800-L EUDAMEDM500A EUDAMEDM500B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429023404 EUDAMED06945429023411 EUDAMED06945429021431 EUDAMED06945429024647 EUDAMED06945429023459 EUDAMED06945429023442 EUDAMED
- Basic UDI-DI
- 69454290SP002R2 EUDAMEDB-06945429021431 EUDAMED69454290SP003R4 EUDAMED69454290SP006RA EUDAMED
- Direct Marketing DI
- 06945429023404 EUDAMED06945429023411 EUDAMED06945429024647 EUDAMED06945429023459 EUDAMED06945429023442 EUDAMED
- EMDN Code
- Z12030302 SYRINGE PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMEDGermany 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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Syringe Pump by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69454290SP002R2 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69454290SP002R2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED c5d0d9f6-059e-4093-a9cd-e67320b3ed70 61 fields · synced Oct 6, 2026
- EUDAMED 72bde7b3-010d-4fa8-b0e1-a2f8c42d5dbb 61 fields · synced May 18, 2026
- EUDAMED 0922257c-bf31-429d-92ff-636f7d0a3410 61 fields · synced May 18, 2026
- EUDAMED e5bdfbdd-8cd4-4d4c-856e-933774b10843 61 fields · synced Jul 8, 2026
- EUDAMED 74144e0c-9739-48ca-b118-a67cc1300c1b 61 fields · synced Jul 10, 2026
- EUDAMED 8b5909b8-12e3-42ac-9e6e-5273950b825a 61 fields · synced Jul 18, 2026