Identity
- Trade Name
- StatSeal (EN) EUDAMED
- Device Name
- StatSeal® Powder EUDAMED
- Model / Reference
- LP636 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00834061005366 EUDAMED
- Basic UDI-DI
- 0834061005366RD EUDAMED
- EMDN Code
- M040504 INORGANIC HAEMOSTATIC DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
StatSeal (EN) by Biolife, LLC — Class IIa — 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 | 0834061005366RD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biolife, LLC
- EUDAMED SRN
- US-MF-000008811
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 15c52f03-2169-466b-8f14-44b2d4bd47ea 61 fields · synced Jun 18, 2026