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Ventilator
EUDAMEDClass IIb (EU MDR)
Ref 112000106Model VS600SModel VS300S/VS500S/VS600S
Identity
- Trade Name
- Ventilator EUDAMED
- Device Name
- Ventilator EUDAMED
- Model / Reference
- VS600S EUDAMED112000106 EUDAMEDVS300S/VS500S/VS600S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972733990580 EUDAMED
- Basic UDI-DI
- B-06972733990580 EUDAMED697273399030105NV_NIVPL EUDAMED
- Direct Marketing DI
- 06972733990580 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 — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06972733990580 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06972733990580 | 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 4cb9ac05-ef43-4cac-ab63-08d6b33acd13 61 fields · synced Jul 12, 2026
- EUDAMED 6564813c-9e44-4a3d-8558-408a42f8f4a3 61 fields · synced May 19, 2026