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Reusable Manual Resuscitators
EUDAMEDClass IIa (EU MDR)
Ref HY-004-04Ref HY-004-06Ref HY-004-05
Identity
- Trade Name
- Reusable Manual Resuscitators EUDAMED
- Device Name
- Reusable Manual Resuscitators EUDAMED
- Model / Reference
- HY-004-04 EUDAMEDHY-004-06 EUDAMEDHY-004-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975834952808 EUDAMED06975834952822 EUDAMED06975834952815 EUDAMED
- Basic UDI-DI
- 697583495CFFSQT2 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
Reusable Manual Resuscitators by Ningbo Hanyue Medical Technology CO., LTD. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
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- SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
- Ventlab — Ventlab Corp. · Class I
- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
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 | 697583495CFFSQT2 | 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 (3)
- EUDAMED c131e8a8-8175-491e-8630-ce512c767c1f 61 fields · synced Oct 6, 2026
- EUDAMED dc289b77-f899-4e4f-8b65-282e64d4ce71 61 fields · synced May 17, 2026
- EUDAMED 8ce7b010-289d-44c4-ad52-6521cf18d433 61 fields · synced May 18, 2026