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Filter, 30F, 22/15mm
EUDAMEDClass IIa (EU MDR)
Ref AF0008Model (J) HME & Filter
Identity
- Trade Name
- Filter, 30F, 22/15mm EUDAMED
- Device Name
- Filter EUDAMED
- Model / Reference
- (J) HME & Filter EUDAMEDAF0008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 44710810101067 EUDAMED
- Basic UDI-DI
- 471081008NNJF8W EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Filter, 30F, 22/15mm by GaleMed Corporation — 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 | 471081008NNJF8W | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6e61be50-0333-424b-ab9b-efc8a651e466 61 fields · synced Jun 19, 2026