Identity
- Trade Name
- Reusable Bacteria Filter EUDAMED
- Device Name
- Reusable Bacteria Filter, 22 M/22 M EUDAMED
- Model / Reference
- FL-70400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FL-70400W2 EUDAMED
- Basic UDI-DI
- B-FL-70400W2 EUDAMED
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Secretion suction kit
Reusable Bacteria Filter by Besmed Health Business Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-FL-70400W2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED fdace2be-3ff8-4736-aea0-5015ff71c5c8 61 fields · synced Jul 16, 2026