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Manual Resuscitators
EUDAMEDClass IIa (EU MDR)
Ref HY-005-02Ref HY-005-2 PVCRef HY-005-03Ref HY-005-3 PVCRef HY-004-01Ref HY-004-3Ref HY-005-01Ref HY-004-02Ref HY-004-1 Adult Silicone
Identity
- Trade Name
- Manual Resuscitators EUDAMED
- Device Name
- Manual Resuscitators EUDAMED
- Model / Reference
- HY-005-02 EUDAMEDHY-005-2 PVC EUDAMEDHY-005-03 EUDAMEDHY-005-3 PVC EUDAMEDHY-004-01 EUDAMEDHY-004-3 EUDAMEDHY-005-01 EUDAMEDHY-004-02 EUDAMEDHY-004-1 Adult Silicone EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975834950699 EUDAMED06975834950439 EUDAMED06975834950682 EUDAMED06975834950446 EUDAMED06975834950736 EUDAMED06975834950477 EUDAMED06975834950705 EUDAMED06975834950729 EUDAMED06975834951214 EUDAMED
- Basic UDI-DI
- 697583495WFSQYB EUDAMED697583495PVCZJ EUDAMED697583495FSQYK EUDAMED697583495SSR2R 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
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
- Ventlab — Ventlab Corp. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- VT Sure — Pulmodyne Inc. · Class II
- 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 | 697583495WFSQYB | 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 (9)
- EUDAMED eee73d58-9a4f-4721-9a48-03c8ae8e73ec 61 fields · synced Oct 6, 2026
- EUDAMED fe4513ff-56b0-49d9-bb6c-9a14909f633f 61 fields · synced May 17, 2026
- EUDAMED 25386f08-e6e6-4651-babd-10ea8cfe3d41 61 fields · synced May 17, 2026
- EUDAMED c0c9aac2-47bc-4799-aa82-95f5f60b7119 61 fields · synced May 18, 2026
- EUDAMED 7785b911-4370-46ea-bf2f-524b6c789341 61 fields · synced May 18, 2026
- EUDAMED b4c73378-bf25-4f7c-928f-8d1fb47abc7a 61 fields · synced May 18, 2026
- EUDAMED 510bb718-8ff1-4b25-8262-7592b9584ae0 61 fields · synced May 18, 2026
- EUDAMED ea500c6c-13ab-48ee-9e7e-fb02cde64ff9 61 fields · synced May 19, 2026
- EUDAMED 870f5aa8-88c6-47bb-b93b-208d91281277 61 fields · synced Jul 28, 2026