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Hydrophobic Filter, 7.6M w/Luer
EUDAMEDClass IIa (EU MDR)
Ref AF0003Model (D) Oxygen Therapy
Identity
- Trade Name
- Hydrophobic Filter, 7.6M w/Luer EUDAMED
- Device Name
- Connector EUDAMED
- Model / Reference
- (D) Oxygen Therapy EUDAMEDAF0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810113208 EUDAMED
- Basic UDI-DI
- 471081008NND97L EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS 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
Hydrophobic Filter, 7.6M w/Luer 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 | 471081008NND97L | 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 fe128a5e-545b-46d6-bd19-14c8410fc625 61 fields · synced Jul 18, 2026