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Single Air Flowmeter with threaded outlet (9/16” UNF), and Mk4, 4-bar Air probe
EUDAMEDClass IIa (EU MDR)
Ref 9910-193
Identity
- Trade Name
- Single Air Flowmeter with threaded outlet (9/16” UNF), and Mk4, 4-bar Air probe EUDAMED
- Device Name
- Medical Gas Flowmeter, Thorpe Tube EUDAMED
- Model / Reference
- 9910-193 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051977002639 EUDAMED
- Basic UDI-DI
- B-05051977002639 EUDAMED
- EMDN Code
- Z120309 MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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
Single Air Flowmeter with threaded outlet (9/16” UNF), and Mk4, 4-bar Air probe by Penlon Limited — Class IIa — MDD — listed in EUDAMED
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-05051977002639 | 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 832573d1-0008-481d-97a9-7dc9fcff1c0e 61 fields · synced Jun 19, 2026