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Twin O₂ Flowmeters, tubing nipples and Mk4 O₂ probe
EUDAMEDClass IIa (EU MDR)
Ref 9910-034
Identity
- Trade Name
- Twin O₂ Flowmeters, tubing nipples and Mk4 O₂ probe EUDAMED
- Device Name
- Medical Gas Flowmeter, Thorpe Tube EUDAMED
- Model / Reference
- 9910-034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051977000505 EUDAMED
- Basic UDI-DI
- B-05051977000505 EUDAMED
- EMDN Code
- Z120309 MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- 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
Twin O₂ Flowmeters, tubing nipples and Mk4 O₂ probe by Penlon Limited — Class IIa — 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-05051977000505 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Penlon Limited
- EUDAMED SRN
- GB-MF-000025115
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 589e4300-d3a3-434f-a2a1-338e60e21e22 61 fields · synced Oct 7, 2026