Identity
- Trade Name
- Filter, 30F, 30M EUDAMED
- Device Name
- Disposable Filter EUDAMED
- Model / Reference
- AF0011 EUDAMEDAF0008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980115790 EUDAMED06923980105616 EUDAMED
- Basic UDI-DI
- 69239801ND2IBP8 EUDAMED69239801ND2IAP6 EUDAMED
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDDenmark 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: Secretion suction kit
Filter, 30F, 30M by GaleMed (Xiamen) Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69239801ND2IBP8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6687a8be-9288-4b43-9864-2412b267ef61 61 fields · synced Jul 8, 2026
- EUDAMED af7bbb30-28e2-40b3-b88b-a6c9326eaffc 61 fields · synced May 17, 2026