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Medical Gas Regulator
EUDAMEDClass IIb (EU MDR)
Ref 777-0001-11 Model Aluminum Oxygen Regulator, Pin Index, 1 x Schrader, Therapy (Fir-Tree Fitting - 0-25LPM) Ref 793-0100-00Model Medical Air (4 Bar) Regulator, Bull-nose (UK) (Medical Air), Therapy Only (Fir-Tree Fitting - 0-15LPM)
Identity
- Trade Name
- Medical Gas Regulator EUDAMED
- Device Name
- Medical Gas Regulator EUDAMED
- Model / Reference
- Aluminum Oxygen Regulator, Pin Index, 1 x Schrader, Therapy (Fir-Tree Fitting - 0-25LPM) EUDAMED777-0001-11 EUDAMEDMedical Air (4 Bar) Regulator, Bull-nose (UK) (Medical Air), Therapy Only (Fir-Tree Fitting - 0-15LPM) EUDAMED793-0100-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05052270302051 EUDAMED
- Basic UDI-DI
- B-05052270302051 EUDAMED
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDPoland 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-05052270302051 | 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 (2)
- EUDAMED b0d4ed8b-e4d3-4298-af4b-01035a9d3f80 61 fields · synced Jun 19, 2026
- EUDAMED 47151f97-00f7-4a4a-942c-0f59fc553b90 61 fields · synced Jun 19, 2026