Identity
- Trade Name
- Hemosep Shaker EUDAMED
- Device Name
- Hemosep Shaker EUDAMED
- Model / Reference
- CR4213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031476224 EUDAMED
- Basic UDI-DI
- 506003147HemosepShakerHQ EUDAMED
- Direct Marketing DI
- 05060031476224 EUDAMED
- EMDN Code
- B0499 AUTOTRANSFUSION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Hemosep Shaker by Brightwake Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506003147HemosepShakerHQ | Class I | 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 3623e35f-1924-4d0b-95db-4291bd5bfdeb 61 fields · synced Jul 28, 2026