Identity
- Trade Name
- Hemosep Intra-Operative Stand EUDAMED
- Device Name
- Hemosep Shaker EUDAMED
- Model / Reference
- CR4213 EUDAMEDCR4429 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031481044 EUDAMED
- Basic UDI-DI
- 506003147HemosepShakerHQ EUDAMED
- EMDN Code
- B99 HAEMATOLOGY AND HAEMOTRANSFUSION 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 Intra-Operative Stand 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 37233d52-126e-4d32-8ba0-09d503deeb71 61 fields · synced Jul 17, 2026