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Hanwell
EUDAMEDClass I (EU MDR)
Ref Neonate/Infant/Child/Adult-S/Adult-M/Adult-L/Adult-XLRef Adult/Pediatric/Infant/Neonate
Identity
- Trade Name
- Hanwell EUDAMED
- Device Name
- CPR MASK EUDAMEDResuscitator EUDAMED
- Model / Reference
- Neonate/Infant/Child/Adult-S/Adult-M/Adult-L/Adult-XL EUDAMEDAdult/Pediatric/Infant/Neonate EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975834950019 EUDAMED06975834950026 EUDAMED
- Basic UDI-DI
- 697583495CPRMASKCP EUDAMED697583495Resuscitator5V EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMEDR03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Hanwell by Ningbo Hanyue Medical Technology CO., LTD. — Class I — 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 | 697583495CPRMASKCP | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Hanyue Medical Technology CO., LTD.
- EUDAMED SRN
- CN-MF-000035941
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 99e9110e-6748-46dd-b7a5-077e0ea44165 61 fields · synced Oct 6, 2026
- EUDAMED a389a88b-3cdb-436b-ab25-c235bb4cdb6d 61 fields · synced May 18, 2026