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Non-rebreathing Valve Complete with 60cmH2O
EUDAMEDClass IIa (EU MDR)
Ref RE-21165
Identity
- Trade Name
- Non-rebreathing Valve Complete with 60cmH2O EUDAMED
- Device Name
- Non-Rebreathing Valve complete with 60 cmH2O EUDAMED
- Model / Reference
- RE-21165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716770211657 EUDAMED
- Basic UDI-DI
- B-04716770211657 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovenia 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
Non-rebreathing Valve Complete with 60cmH2O by Besmed Health Business Corp. — 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-04716770211657 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED 05e5635e-88ab-4ae2-a764-6cb05b921173 61 fields · synced Oct 6, 2026