Identity
- Trade Name
- Hemosep Intra-Operative Kit EUDAMED
- Device Name
- Hemosep Intra-Operative Kit EUDAMED
- Model / Reference
- CR4428 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031481006 EUDAMED
- Basic UDI-DI
- B-05060031481006 EUDAMED
- EMDN Code
- B0402 INTRA- AND POSTOPERATIVE BLOOD COLLECTION AND REINFUSION ONLY DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa 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 Intra-Operative Kit by Brightwake Limited — Class IIa — 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-05060031481006 | Class IIa | 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 abbf7ccb-cdee-4598-8b47-8f126e7a499f 61 fields · synced Jul 9, 2026