Identity
- Trade Name
- Manual Resuscitators EUDAMED
- Device Name
- Manual Resuscitators EUDAMED
- Model / Reference
- HY-005-1 PVC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975834950002 EUDAMED
- Basic UDI-DI
- 697583495PVCZJ EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Pulmonary resuscitator, manual, single-use
Manual Resuscitators by Ningbo Hanyue Medical Technology CO., LTD. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulmonary resuscitator, manual, single-use.
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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 | 697583495PVCZJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Hanyue Medical Technology CO., LTD.
- EUDAMED SRN
- CN-MF-000035941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 372767e4-4b67-4e09-bcaa-a0d3a761ce81 61 fields · synced Jun 19, 2026