Neonatal phototherapy eye mask
by Ontecklong(Nanjing) Medical Supply Corporation Limited 16 variants
Ref Type VII LargeModel 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
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697472926NPEM02V4 06974729260196 | Date3 Jun 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Neonatal phototherapy eye mask
- 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, Type VII Large
- Primary DI / UDI-DI
- 06974729260196
- Basic UDI-DI
- 697472926NPEM02V4
- EMDN Code
- V0299 Neonatology and paediatric devices - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000047984
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No