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Neonatal phototherapy eye mask
EUDAMEDClass I (EU MDR)
Ref Type IV Large Model Type II Large / Type II Medium / Type II Small Type III Large / Type III Medium / Type III Small Type IV Large / Type IV Medium / Type IV Small Type IV-N Large / Type IV-N Medium / Type IV-N Small Type VII Large / Type VII Medium/Type VII Small
Identity
- Device Name
- Neonatal phototherapy eye mask EUDAMED
- Model / Reference
- Type II Large / Type II Medium / Type II Small Type III Large / Type III Medium / Type III Small Type IV Large / Type IV Medium / Type IV Small Type IV-N Large / Type IV-N Medium / Type IV-N Small Type VII Large / Type VII Medium/Type VII Small EUDAMEDType IV Large EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974729260141 EUDAMED
- Basic UDI-DI
- 697472926NPEM02V4 EUDAMED
- EMDN Code
- V0299 NEONATOLOGY AND PAEDIATRIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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: Assistive crawler/mobility board
Neonatal phototherapy eye mask by Ontecklong(Nanjing) Medical Supply Corporation Limited — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697472926NPEM02V4 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000047984
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5a50f98f-30e8-4689-8d72-ca409788b403 61 fields · synced Oct 7, 2026