Identity
- Trade Name
- CSF61S EUDAMEDB Medical Systems FDA UDI
- Generic Name
- Rapid-contact laboratory freezer FDA UDI
- Device Name
- Contact Shock Freezer EUDAMEDPlasma contact shock freezer FDA UDI
- Model / Reference
- 991.8920.** EUDAMEDCSF61S FDA UDI
- Description
- Plasma contact shock freezer FDA UDI
Identifiers
- Catalog Number
- 991.8926.** FDA UDI
- Primary DI / UDI-DI
- 05450104540875 EUDAMEDFDA UDI
- Basic UDI-DI
- 05450104511103A8 EUDAMED
- FDA Product Code
- KSE FDA UDI
- EMDN Code
- Z121702 BLOOD AND BLOOD COMPONENTS FREEZERS EUDAMED
- GMDN Term
- Rapid-contact laboratory freezer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9700 FDA UDI
- Market of Registration
- Slovenia 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
Csf61s by B Medical Systems S.à r.l. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 05450104511103A8 | 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 596200ab-a9d4-48ac-bcff-eb04acf1cc87 61 fields · synced Jul 16, 2026
- FDA UDI 4c1609b5-3f3f-43aa-86e5-e3d26aedf7e6 35 fields · synced May 29, 2026