Identity
- Trade Name
- BPR Medical EUDAMEDAGSS Exhalation Valve with Mouthpiece EUDAMED
- Device Name
- Ultraflow Exhalation Valve with AGSS for Demand Valve (1) EUDAMEDDemand Valve EUDAMED
- Model / Reference
- 828-0004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060274502681 EUDAMED
- Basic UDI-DI
- B-05060274502681 EUDAMED5060274500096D EUDAMED
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMEDR9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER 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: Secretion suction kit
BPR Medical by Bpr Medical Limited — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05060274502681 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05060274502681 | 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 a566d77c-fc26-4009-86d0-6d9e0ccbf23c 61 fields · synced Jul 17, 2026
- EUDAMED 86c05ce8-1bdd-4d2a-afe9-ca7e37d8db26 61 fields · synced May 19, 2026