Identity
- Trade Name
- Filter 22F/15M w/Luer EUDAMED
- Device Name
- Disposable Filter EUDAMED
- Model / Reference
- AF0005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980105586 EUDAMED
- Basic UDI-DI
- 69239801ND2IAP6 EUDAMED
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 22F/15M w/Luer by GaleMed (Xiamen) Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Secretion suction kit.
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- Suction Catheter Kits, Disposable — Dynarex Corp. · Class I
- AirLife™ Mini-Filter/S, Disposable — AirLife Finland Oy · Class IIa
- HITECARE — Ningbo Boya Medical Equipment Co., Ltd · Class IIa
- RespVac™ — CUTTING EDGE HC BRANDS LLC · Class I
- Breathing Filter — Ningbo Luke Medical Devices Co.,LTD · Class IIa
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- Bioseal Inc. — BIOSEAL · Class I
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 | 69239801ND2IAP6 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 40cf082d-864f-439f-9ec9-cb8b8a9e2f7c 61 fields · synced Jun 17, 2026