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Positive Expiratory Pressure (PEP) Therapy device
EUDAMEDClass I (EU MDR)
Ref 8020060
Identity
- Device Name
- Positive Expiratory Pressure (PEP) Therapy device EUDAMED
- Model / Reference
- 8020060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05030267160754 EUDAMED
- Basic UDI-DI
- 05030267PEPTHERER EUDAMED
- EMDN Code
- Z12159009 EQUIPMENT FOR REMOVAL OF SECRETIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Positive Expiratory Pressure (PEP) Therapy device by Intersurgical Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 05030267PEPTHERER | Class I | Active |
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Manufacturer
- Manufacturer
- Intersurgical Ltd
- EUDAMED SRN
- GB-MF-000004798
- Authorised Representative
- UAB Intersurgical LT-AR-000003907
Sources (1)
- EUDAMED f1b9cb58-b232-4c9e-b890-2bbdff0c6dc4 61 fields · synced Jun 18, 2026