Identity
- Trade Name
- MT100 EUDAMEDB Medical Systems FDA UDI
- Generic Name
- Blood refrigerator/incubator FDA UDI
- Device Name
- Blood refrigerator/incubator EUDAMEDBlood storage refrigerator FDA UDI
- Model / Reference
- 991.2370.** EUDAMEDMT100 FDA UDI
- Description
- Blood storage refrigerator FDA UDI
Identifiers
- Catalog Number
- 991.2370.** FDA UDI
- Primary DI / UDI-DI
- 05450104061837 EUDAMEDFDA UDI
- Basic UDI-DI
- 05450104511066AT EUDAMED
- FDA Product Code
- KSE FDA UDI
- EMDN Code
- Z121701 BLOOD BANKS REFRIGERATORS EUDAMED
- GMDN Term
- Blood refrigerator/incubator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9700 FDA UDI
- Market of Registration
- Romania 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Mt100 by B Medical Systems S.à r.l. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood refrigerator.
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- Horizon Series™ — HELMER Inc. · Class II
- Cardinal Health Blood Bank Refrigerator — KEY SCIENTIFIC INC · Class II
- Horizon Series™ — HELMER Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 05450104511066AT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- B Medical Systems S.à r.l.
- EUDAMED SRN
- LU-MF-000000128
Sources (2)
- EUDAMED 7751a3e0-5a4e-411a-9934-2117c428b6fa 61 fields · synced Jun 19, 2026
- FDA UDI 6a500af0-52ae-4e01-bb17-e3fb71c87af1 35 fields · synced May 30, 2026