Horizon Series
by Helmer Scientific 4 variants
Ref HPR245-GXCModel i.Series
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 | Number081639402TFR0116M 00816394022388 | Date24 Jun 2026 | 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- Withdrawn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
- Refrigerator
- Model / Reference
- i.Series, HPR245-GXC
- Primary DI / UDI-DI
- 00816394022388
- Basic UDI-DI
- 081639402TFR0116M
- Direct Marketing DI
- 00816394022388
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000003326
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Helmer Scientific
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