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Ventilator
EUDAMEDClass IIb (EU MDR)
Ref 112000108Model VS300S/VS500S/VS600SModel VS300S
Identity
- Trade Name
- Ventilator EUDAMED
- Device Name
- Ventilator EUDAMED
- Model / Reference
- VS300S/VS500S/VS600S EUDAMED112000108 EUDAMEDVS300S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972733990566 EUDAMED
- Basic UDI-DI
- 697273399030105NV_NIVPL EUDAMEDB-06972733990566 EUDAMED
- Direct Marketing DI
- 06972733990566 EUDAMED
- EMDN Code
- Z1203010503 NEONATAL/PAEDIATRIC PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ventilator by HEYER Medical Co., Ltd. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697273399030105NV_NIVPL | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697273399030105NV_NIVPL | Class IIb | Active |
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Manufacturer
- Manufacturer
- HEYER Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014712
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 96da01d8-0a65-4d89-a048-c772581f3077 61 fields · synced Jul 12, 2026
- EUDAMED f9c3a28b-2bc8-4213-9d42-8d2a3c90f17c 61 fields · synced May 16, 2026