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NIBP Cuff
EUDAMEDClass I (EU MDR)
Ref CM-M04-019Model CM-M04-001Ref CM-M04-012Ref CM-M04-015Ref CM-M04-009Ref CM-M04-013Ref CM-M04-008Ref CM-M04-016Ref CM-M04-014Ref CM-M04-004Ref CM-M04-003Ref CM-M04-017Ref CM-M04-005Ref CM-M04-006
Identity
- Trade Name
- NIBP Cuff EUDAMED
- Device Name
- NIBP Cuff EUDAMED
- Model / Reference
- CM-M04-001 EUDAMEDCM-M04-019 EUDAMEDCM-M04-012 EUDAMEDCM-M04-015 EUDAMEDCM-M04-009 EUDAMEDCM-M04-013 EUDAMEDCM-M04-008 EUDAMEDCM-M04-016 EUDAMEDCM-M04-014 EUDAMEDCM-M04-004 EUDAMEDCM-M04-003 EUDAMEDCM-M04-017 EUDAMEDCM-M04-005 EUDAMEDCM-M04-006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429081619 EUDAMED06945429081541 EUDAMED06945429081572 EUDAMED06945429081510 EUDAMED06945429081558 EUDAMED06945429081503 EUDAMED06945429081589 EUDAMED06945429081565 EUDAMED06945429081466 EUDAMED06945429081459 EUDAMED06945429081596 EUDAMED06945429081473 EUDAMED06945429081480 EUDAMED
- Basic UDI-DI
- 69454290CM003JX EUDAMED
- Direct Marketing DI
- 06945429081619 EUDAMED06945429081541 EUDAMED06945429081572 EUDAMED06945429081510 EUDAMED06945429081558 EUDAMED06945429081503 EUDAMED06945429081589 EUDAMED06945429081565 EUDAMED06945429081466 EUDAMED06945429081459 EUDAMED06945429081596 EUDAMED06945429081473 EUDAMED06945429081480 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NIBP Cuff by Shenzhen Comen Medical Instruments Co., LTD. — Class I — 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 | 69454290CM003JX | Class I | 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 (13)
- EUDAMED 169d568c-9a02-4002-aae8-032aef41a0f0 61 fields · synced Oct 6, 2026
- EUDAMED 7c313187-1750-415f-996f-08ac0618a88b 61 fields · synced May 16, 2026
- EUDAMED 30931a63-9fd9-475f-b1d0-22406b83c4b4 61 fields · synced May 16, 2026
- EUDAMED 9c558038-cea4-4fb3-a35c-bfec59455072 61 fields · synced May 17, 2026
- EUDAMED 10b70ef0-486f-4c77-a7f5-8282303dffe5 61 fields · synced May 17, 2026
- EUDAMED 88ece44c-164d-4ec2-9229-27d298690d66 61 fields · synced May 17, 2026
- EUDAMED 664a5c84-7465-4070-a8c1-fdec2f3840bc 61 fields · synced May 17, 2026
- EUDAMED f21129c2-30fe-4687-94b2-bf950339f50e 61 fields · synced May 17, 2026
- EUDAMED ccdf4ef0-21d0-46d0-8f29-3aedfe362c9a 61 fields · synced May 17, 2026
- EUDAMED bba04a9e-1fd7-495c-9a28-036b7e895270 61 fields · synced May 18, 2026
- EUDAMED b726ee1b-0b5f-4919-86a7-a4c59377a631 61 fields · synced May 18, 2026
- EUDAMED a07d1532-d77d-48eb-b65b-7f7a17755b49 61 fields · synced May 18, 2026
- EUDAMED d59540fe-64d9-4887-a254-ca855f34cfbb 61 fields · synced May 19, 2026