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Neonatal phototherapy eye mask
EUDAMEDClass I (EU MDR)
Ref Type IV SmallModel 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 SmallRef Type VII MediumRef Type VII LargeRef Type IV-N LargeRef Type I LargeModel Type I Large / Type I Medium / Type I SmallRef Type I SmallRef Type IV-N SmallRef Type IV-N MediumRef Type II SmallRef Type IV MediumRef Type IV Large Ref Type I MediumRef Type II Large
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 Small EUDAMEDType VII Medium EUDAMEDType VII Large EUDAMEDType IV-N Large EUDAMEDType I Large / Type I Medium / Type I Small EUDAMEDType I Large EUDAMEDType I Small EUDAMEDType IV-N Small EUDAMEDType IV-N Medium EUDAMEDType II Small EUDAMEDType IV Medium EUDAMEDType IV Large EUDAMEDType I Medium EUDAMEDType II Large EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974729260158 EUDAMED06974729260202 EUDAMED06974729260196 EUDAMED06974729260226 EUDAMED06974729260011 EUDAMED06974729260035 EUDAMED06974729260240 EUDAMED06974729260233 EUDAMED06974729260103 EUDAMED06974729260059 EUDAMED06974729260141 EUDAMED06974729260028 EUDAMED06974729260097 EUDAMED
- Basic UDI-DI
- 697472926NPEM02V4 EUDAMED697472926NPEM01V2 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 — 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 (13)
- EUDAMED 130c92a2-df13-450f-9ed3-24319c682aff 61 fields · synced Jul 31, 2026
- EUDAMED b13e76b0-3388-4c08-ad7c-349cde033a76 61 fields · synced May 11, 2026
- EUDAMED a434db45-ac3f-4c61-9bac-605f1772099d 61 fields · synced May 16, 2026
- EUDAMED 9c97e7c2-4f3a-47d9-a301-e33688024590 61 fields · synced May 17, 2026
- EUDAMED d3884a80-6e3a-4f73-ad74-1eaace52d2a7 61 fields · synced May 17, 2026
- EUDAMED e6cebbb7-2cbb-4432-98dc-0257702746b4 61 fields · synced May 17, 2026
- EUDAMED 5e789c85-c40d-4259-80e1-edb13caeab9c 61 fields · synced May 18, 2026
- EUDAMED 2ebec4e4-6d9b-4f6d-bed4-25cd0e6e54b8 61 fields · synced May 18, 2026
- EUDAMED 76d6202c-399a-49b3-8234-b4099f13ffc0 61 fields · synced May 18, 2026
- EUDAMED 01d6dccc-0361-4cda-9a51-ef3993721b13 61 fields · synced May 18, 2026
- EUDAMED 5a50f98f-30e8-4689-8d72-ca409788b403 61 fields · synced May 18, 2026
- EUDAMED 6ea72aba-a9f5-4ba8-9479-d4520bf2eb2b 61 fields · synced May 18, 2026
- EUDAMED 7c4891d9-3d86-44de-8b6d-b1923adc2bd9 61 fields · synced May 19, 2026