Identity
- Trade Name
- Ventilator EUDAMED
- Device Name
- Ventilator EUDAMED
- Model / Reference
- VG55、VG65 EUDAMED112000100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972733990702 EUDAMED
- Basic UDI-DI
- 697273399030105NIV6X EUDAMED
- Direct Marketing DI
- 06972733990702 EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL 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 — listed in EUDAMED — regulatory data on deviCERTS
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 | 697273399030105NIV6X | 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 (1)
- EUDAMED f28b0d67-a950-4bfe-97b7-746d1615c35b 61 fields · synced Jun 20, 2026