Identity
- Device Name
- POWERbreathe K-Series EUDAMED
- Model / Reference
- PBK1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060127401819 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 (1)
- EUDAMED f54e95e2-60aa-4820-a2c1-f8906186bede 61 fields · synced Jun 20, 2026