Identity
- Trade Name
- BloodSTOP iX EUDAMED
- Device Name
- BloodSTOP iX EUDAMED
- Model / Reference
- BS-iX20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000004095IX20EUL5 EUDAMED
- Basic UDI-DI
- B-USMF000004095IX20EUL5 EUDAMED
- EMDN Code
- M040501 POLYSACCHARIDE HAEMOSTATIC DRESSINGS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Greece 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
BloodSTOP iX by LifeScience PLUS, Inc. — Class III — 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-USMF000004095IX20EUL5 | Class III | Active |
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Manufacturer
- Manufacturer
- LifeScience PLUS, Inc.
- EUDAMED SRN
- US-MF-000004095
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 35b837db-731e-4648-b38a-7709c9dabb43 61 fields · synced Jun 9, 2026