Identity
- Trade Name
- Prolife PN Basic EUDAMEDCompressor Nebulizer Prolife PN Basic EUDAMED
- Device Name
- Aerosoltherapy Nebulizer EUDAMED
- Model / Reference
- 92938 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970229251665 EUDAMED
- Basic UDI-DI
- 697022925GCE8XXEM EUDAMED
- EMDN Code
- Z12159002 AEROSOL EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
Prolife PN Basic by Globalcare Medical Technology Co., Ltd. — Class IIa — 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 | 697022925GCE8XXEM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Globalcare Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033595
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (2)
- EUDAMED 1f62c1e7-b255-4221-b238-e2145c38ab59 61 fields · synced Jul 9, 2026
- EUDAMED 09cebdf0-80e2-453a-8f85-8049f15eec28 61 fields · synced Jul 9, 2026