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Horizon Series™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref HBR105-GXModel Horizon Series
by HELMER Inc.
Identity
- Trade Name
- Horizon Series EUDAMEDHorizon Series™ FDA UDI
- Generic Name
- Blood refrigerator FDA UDI
- Device Name
- Refrigerator EUDAMEDBlood Bank Refrigerator - Undercounter, 5 cu ft FDA UDI
- Model / Reference
- HBR105-GX EUDAMEDFDA UDIHorizon Series EUDAMED
- Description
- Blood Bank Refrigerator - Undercounter, 5 cu ft FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00816394021053 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816394021053 EUDAMED
- FDA Product Code
- KSE FDA UDI
- EMDN Code
- Z121701 BLOOD BANKS REFRIGERATORS EUDAMED
- GMDN Term
- Blood refrigerator 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 refrigerator
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 refrigerator.
- BL 100 PRO-ACTIVE E — Philipp Kirsch GmbH · Class IIa
- BLOODBANK — FRI.MED. S.R.L. · Class IIa
- Medical Refrigerator — Jinan Biobase Biotech Co., Ltd. · Class I
- Cardinal Health Blood Bank Refrigerator — KEY SCIENTIFIC INC · Class II
- BL 300 ULTIMATE E — Philipp Kirsch GmbH · Class IIa
- HEMOVAULT by ACCUCOLD — FELIX STORCH, INC. · Class II
- BLOODBANK — FRI.MED. S.R.L. · Class IIa
- Follett — Follett Corporation · 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 f7677589-5cfa-442d-bfe8-c5ce15bde3a1 35 fields · synced Jun 19, 2026
- EUDAMED 83f9e1e8-6d29-440a-9df6-e5e63767cb8c 61 fields · synced Jun 19, 2026