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Horizon Series™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref HLF120-GXModel Horizon Series
by HELMER Inc.
Identity
- Trade Name
- Horizon Series EUDAMEDHorizon Series™ FDA UDI
- Generic Name
- Blood plasma freezer FDA UDI
- Device Name
- Freezer EUDAMED-30°C Laboratory Freezer, 20 cu ft FDA UDI
- Model / Reference
- HLF120-GX EUDAMEDFDA UDIHorizon Series EUDAMED
- Description
- -30°C Laboratory Freezer, 20 cu ft FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816394021527 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816394021527 EUDAMED
- FDA Product Code
- KSE FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Blood plasma freezer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9700 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood plasma freezer
Horizon Series™ by HELMER Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood plasma freezer.
- Biotecno — BIOTECNO INDUSTRIA E COMERCIO LTDA · Class II
- Master-Bilt — NOR-LAKE, INCORPORATED · Class II
- Follett — Follett Corporation · Class II
- Follett — Follett Corporation · Class II
- Follett — Follett Corporation · Class II
- Biotecno — BIOTECNO INDUSTRIA E COMERCIO LTDA · Class II
- Biotecno — BIOTECNO INDUSTRIA E COMERCIO LTDA · Class II
- Biotecno — BIOTECNO INDUSTRIA E COMERCIO LTDA · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- HELMER Inc.
Sources (2)
- FDA UDI 9aec0381-3cab-4bbc-947b-348f26f4e743 34 fields · synced Jul 18, 2026
- EUDAMED 3ed761a5-30d0-4407-b4b6-48c31b0b99da 61 fields · synced Jul 18, 2026