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Prizma/Plus Comfort NAZALNI ASPIRATOR
EUDAMEDClass IIa (EU MDR)
Ref 3068000Model ME8202X
Identity
- Trade Name
- Prizma/Plus Comfort NAZALNI ASPIRATOR EUDAMED
- Device Name
- Powered Nasal Aspirator EUDAMED
- Model / Reference
- ME8202X EUDAMED3068000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872280460 EUDAMED
- Basic UDI-DI
- 471987228ME8202XG4 EUDAMED
- EMDN Code
- R05010301 SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS EUDAMED
Classification
- Device Class
- Class IIa 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
Prizma/Plus Comfort NAZALNI ASPIRATOR by Asia Connection 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 | 471987228ME8202XG4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Asia Connection Co., Ltd.
- EUDAMED SRN
- TW-MF-000006739
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 647ded67-e2bf-4f0f-aa63-84a338609e9e 61 fields · synced Oct 5, 2026