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POWERbreathe K-Series
EUDAMEDClass I (EU MDR)
Ref PBKH2Ref PBK3Ref PBKHP2Ref PBK4Ref PBK5Ref PBKH1
Identity
- Device Name
- POWERbreathe K-Series EUDAMED
- Model / Reference
- PBKH2 EUDAMEDPBK3 EUDAMEDPBKHP2 EUDAMEDPBK4 EUDAMEDPBK5 EUDAMEDPBKH1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060127401871 EUDAMED05060127401833 EUDAMED05060127405886 EUDAMED05060127401840 EUDAMED05060127401857 EUDAMED05060127401864 EUDAMED05060127405879 EUDAMED
- Basic UDI-DI
- 5060127400003NN EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
POWERbreathe K-Series by POWERbreathe International Ltd — Class I — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5060127400003NN | Class I | Active |
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Manufacturer
- Manufacturer
- POWERbreathe International Limited
- EUDAMED SRN
- UK-MF-000045438
- Authorised Representative
- HaB GmbH DE-AR-000041460
Sources (7)
- EUDAMED 57ccca23-9291-4c3e-afdb-735f545e5c74 61 fields · synced Jul 31, 2026
- EUDAMED ae929b13-9039-49e3-a887-f8d0f7a46748 61 fields · synced May 11, 2026
- EUDAMED ae2b27af-3022-461b-ae2b-a012d254475c 61 fields · synced May 17, 2026
- EUDAMED 5b637488-3179-40ca-af74-428e2085b490 61 fields · synced May 17, 2026
- EUDAMED cdc1d785-6c35-4b1c-97f8-d777e89c54df 61 fields · synced May 18, 2026
- EUDAMED b6b28e89-0492-47bd-b129-f100ffbb8a60 61 fields · synced May 19, 2026
- EUDAMED abac1882-f612-4200-acd3-e0fe57fead46 61 fields · synced May 19, 2026