Identity
- Trade Name
- Breathing Bags EUDAMED
- Device Name
- Breathing Bags EUDAMED
- Model / Reference
- HXN EUDAMED0.5L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970531332816 EUDAMED
- Basic UDI-DI
- 697053133bblVD EUDAMED
- Direct Marketing DI
- 06970531332816 EUDAMED
- EMDN Code
- R03020101 ANAESTHESIA BALLOONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Breathing Bags 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 | 697053133bblVD | 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 0df798fc-3b0a-4f55-8941-06b8035513c2 61 fields · synced Jun 18, 2026