Identity
- Trade Name
- Disposable Breathing Filter EUDAMED
- Device Name
- Disposable Breathing Filter EUDAMED
- Model / Reference
- HMEF EUDAMEDHME-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970531332226 EUDAMED
- Basic UDI-DI
- 697053133hbfVX EUDAMED
- Direct Marketing DI
- 16970531332226 EUDAMED
- EMDN Code
- R0499 RESPIRATORY 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
Disposable Breathing Filter by Shaoxing Undis Medical Technology Co., Ltd — 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 | 697053133hbfVX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Undis Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000002187
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 146a5545-3423-47cc-bfd2-e3a1d0fc60d4 61 fields · synced Jun 18, 2026