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Medical Gas Regulator
EUDAMEDClass IIb (EU MDR)
Ref 780-0504-20 Model Oxygen Regulator, CGA540 (USA), 2 x DIN 13260-2:2004 (Hayer), Non-Therapy-SL
Identity
- Trade Name
- Medical Gas Regulator EUDAMED
- Device Name
- Medical Gas Regulator EUDAMED
- Model / Reference
- Oxygen Regulator, CGA540 (USA), 2 x DIN 13260-2:2004 (Hayer), Non-Therapy-SL EUDAMED780-0504-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05052270302297 EUDAMED
- Basic UDI-DI
- B-05052270302297 EUDAMED
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medical Gas Regulator by BNOS MediTECH — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-05052270302297 | Class IIb | Active |
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Manufacturer
- Manufacturer
- BNOS MediTECH
- EUDAMED SRN
- GB-MF-000008883
- Authorised Representative
- Medical Device Management Ltd IE-AR-000002496
Sources (1)
- EUDAMED f925dcc2-08f2-43e7-abb9-6ae5e8dc9e73 61 fields · synced Jun 17, 2026