Cradle
Ref OG-PH05-HLRModel OG-PH05-HLM
Cradle (OG-PH05-HLR) is a Class A device made by OSANG HEALTHCARE Co., Ltd., registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 880911590OGPH05HLMG9), active as of 25 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number880911590OGPH05HLMG9 | Date3 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 880911590OGPH05HLMG9
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- Withdrawn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/IVDR Active
Specification
- Device name
- GluNEO H Link Blood Glucose/Blood β-Ketone Test Meter
- Model / reference
- OG-PH05-HLM, OG-PH05-HLR
- Primary DI / UDI-DI
- 08800323059462, 08800323055402
- Basic UDI-DI
- 880911590OGPH05HLMG9
- Direct marketing DI
- 08800323059462
- EMDN code
- W020106019099 Various diabetes monitoring instruments - other
- Device class
- Class A
- EU registration type
- Standard device
- EU market of registration
- GermanyItaly
Manufacturer details
- EUDAMED SRN
- KR-MF-000032605
- Authorised representative
- Obelis s.a. BE-AR-000000106
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