Identity
- Trade Name
- AllPEP EUDAMED
- Device Name
- Oscillating Positive Expiratory Pressure EUDAMED
- Model / Reference
- EN-PEP-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719882300219 EUDAMED
- Basic UDI-DI
- 471988230ENPEP010211HH EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
AllPEP by Enchant Tek Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233855 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 471988230ENPEP010211HH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Enchant Tek Co., Ltd.
- EUDAMED SRN
- TW-MF-000037003
- Authorised Representative
- Wellell Iberia S.L. ES-AR-000003668
Sources (2)
- EUDAMED d2bb0a1a-ace9-4273-b7ca-e74c02c796b8 61 fields · synced Jul 9, 2026
- FDA 510(k) K233855 1 fields · synced May 18, 2026