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Manual Resuscitators
EUDAMEDClass IIa (EU MDR)
Ref AN128033NSModel AN128031NS、AN128032NS、AN128033NSRef AN128032NSRef AN128031NS
Identity
- Trade Name
- Manual Resuscitators EUDAMED
- Device Name
- Manual Resuscitators EUDAMED
- Model / Reference
- AN128031NS、AN128032NS、AN128033NS EUDAMEDAN128033NS EUDAMEDAN128032NS EUDAMEDAN128031NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013964669 EUDAMED06972013964652 EUDAMED06972013964645 EUDAMED
- Basic UDI-DI
- 697201396MU2ANNNNSMR001LC EUDAMED
- Direct Marketing DI
- 06972013964669 EUDAMED06972013964652 EUDAMED06972013964645 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa 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 Multigate 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
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- 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 | 697201396MU2ANNNNSMR001LC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (6)
- EUDAMED 43b99e0e-2393-47a2-944b-5214a6dac6a6 61 fields · synced Jul 25, 2026
- EUDAMED 5429d7ca-2cde-4661-ad02-8bcb29aa91ed 61 fields · synced May 18, 2026
- EUDAMED 72a4f6ff-586f-4682-b44c-b6b634f36eab 61 fields · synced May 18, 2026
- EUDAMED 78d73b1d-add8-4c80-a7f6-5d05a4116b1d 61 fields · synced Jun 19, 2026
- EUDAMED 15108296-c635-44e2-b612-bd0c00cdf161 61 fields · synced Jul 13, 2026
- EUDAMED e7e91fa5-2f4d-4566-bfc3-4af599e12327 61 fields · synced Jul 25, 2026