Identity
- Trade Name
- Hemosep Cell Concentrator Pack EUDAMED
- Device Name
- Hemosep Cell Concentrator Pack EUDAMED
- Model / Reference
- CR4426 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031481129 EUDAMED
- Basic UDI-DI
- B-05060031481129 EUDAMED
- EMDN Code
- B0402 INTRA- AND POSTOPERATIVE BLOOD COLLECTION AND REINFUSION ONLY DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Hemosep Cell Concentrator Pack by Brightwake Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060031481129 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Brightwake Limited
- EUDAMED SRN
- GB-MF-000012039
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED 56d24301-af23-4e07-8460-86b48d5be5e8 61 fields · synced Jul 16, 2026