← Back to catalogue
Manual Resuscitator
EUDAMEDClass IIa (EU MDR)
Ref PA40622112Model SEBSRef PA40613111Model SiliconeRef PA40683113Model PVC
Identity
- Trade Name
- Manual Resuscitator EUDAMED
- Device Name
- Manual Resuscitator EUDAMED
- Model / Reference
- SEBS EUDAMEDPA40622112 EUDAMEDSilicone EUDAMEDPA40613111 EUDAMEDPVC EUDAMEDPA40683113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310909662 EUDAMED06923310902557 EUDAMED06923310909631 EUDAMED
- Basic UDI-DI
- 69233109PA40629C EUDAMED69233109PA40619A EUDAMED69233109PA40689Q 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 Resuscitator by Hangzhou Formed Medical Devices 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 | 69233109PA40629C | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED bb7065b2-9654-43bf-ad5e-bbbb902eaf05 61 fields · synced Jul 24, 2026
- EUDAMED 76ccbd4e-34ff-49c5-bdcd-2b178c6076c3 61 fields · synced May 18, 2026
- EUDAMED 4dc19c30-d9e6-4a10-857d-2df4bda4780e 61 fields · synced May 19, 2026