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Single Patient Use Manual Resuscitator Unit
EUDAMEDClass IIa (EU MDR)
Ref BV56312RModel BV Type
Identity
- Device Name
- Single Patient Use Manual Resuscitator Unit EUDAMED
- Model / Reference
- BV Type EUDAMEDBV56312R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872870371 EUDAMED
- Basic UDI-DI
- B-04719872870371 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary resuscitator, manual, single-use
Single Patient Use Manual Resuscitator Unit by Omnimate Enterprise Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719872870371 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Omnimate Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000027058
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED a45c2200-b2d5-4d01-9d5f-e5aa3a101e08 61 fields · synced Jun 18, 2026