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Insufflation Filter with Tubing Set
EUDAMEDClass IIa (EU MDR)
Ref SU102501Model AIF-400Z, AIF-403Z, AIF-430Z, AIF-4400, AIF-460Z, AIF-4700, AIF-500Z, AIF-530Z, AIF-540Z, AIF-560Z, AIF-600Z, AIF-630Z, AIF-640Z, AIF-660Z, AIF-670Z
Identity
- Trade Name
- Insufflation Filter with Tubing Set EUDAMED
- Device Name
- Insufflation Filter with Tubing Set EUDAMED
- Model / Reference
- AIF-400Z, AIF-403Z, AIF-430Z, AIF-4400, AIF-460Z, AIF-4700, AIF-500Z, AIF-530Z, AIF-540Z, AIF-560Z, AIF-600Z, AIF-630Z, AIF-640Z, AIF-660Z, AIF-670Z EUDAMEDSU102501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09341601012452 EUDAMED
- Basic UDI-DI
- 471160599AIF0143 EUDAMED
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
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: Microbial medical gas filter, single-use
Insufflation Filter with Tubing Set by Advanced Medical Design Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Microbial medical gas filter, single-use.
- ECO slimline — GVS Filter Technology UK Ltd · Class IIa
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Ventlab — Ventlab Corp. · Class II
- Disposable Heat and Moisture Exchanger Filters — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- Ventlab — Ventlab Corp. · Class II
- Pentair — Pentair Filtration Solutions · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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 | 471160599AIF0143 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced Medical Design Co., Ltd.
- EUDAMED SRN
- TW-MF-000019772
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 397ed579-4bb4-4163-833f-62abb860a527 61 fields · synced Jun 18, 2026