Identity
- Trade Name
- 4SEAL® Proszek hemostatyczny 1g EUDAMED
- Device Name
- 4SEAL® Hemostatic Powder 1 g EUDAMED
- Model / Reference
- 1203-HP001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060771920114 EUDAMED
- Basic UDI-DI
- B-15060771920114 EUDAMED
- EMDN Code
- M040501 POLYSACCHARIDE HAEMOSTATIC DRESSINGS EUDAMED
Classification
- Device Class
- Class III 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
4SEAL® Proszek hemostatyczny 1g by Grena Biomed Limited — 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-15060771920114 | Class III | Active |
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Manufacturer
- Manufacturer
- Grena Biomed Limited
- EUDAMED SRN
- GB-MF-000007432
- Authorised Representative
- MDML Intl Limited IE-AR-000001156
Sources (1)
- EUDAMED 1a1957a1-27d6-4b3e-8c81-34426bf216ca 61 fields · synced Jul 9, 2026