Identity
- Trade Name
- Exhalation Valve with Mouthpiece EUDAMEDBPR Medical EUDAMED
- Device Name
- Demand Valve EUDAMEDUltraflow Exhalation Valve with Mouthpiece (1) EUDAMED
- Model / Reference
- 828-0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060274500014 EUDAMED
- Basic UDI-DI
- 5060274500096D EUDAMEDB-05060274500014 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMEDR040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Exhalation Valve with Mouthpiece by Bpr Medical Limited — Class IIa — MDD, MDR — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 5060274500096D | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5060274500096D | Class IIa | Active |
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Manufacturer
- Manufacturer
- BPR Medical Limited
- EUDAMED SRN
- GB-MF-000003347
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 29447c68-96a5-4d9e-aeeb-7aa0ff9a7c10 61 fields · synced Aug 3, 2026
- EUDAMED ca60873e-004c-47e7-aca0-c96b091e82fb 61 fields · synced May 17, 2026