Identity
- Trade Name
- StatSeal EUDAMEDStatSeal® FDA UDI
- Generic Name
- Non-organic haemostatic agent FDA UDI
- Device Name
- StatSeal Disc - Advanced EUDAMEDStatSeal® Disc - Advanced FDA UDI
- Model / Reference
- DA018 EUDAMEDFDA UDI
- Description
- StatSeal® Disc - Advanced FDA UDI
Identifiers
- Catalog Number
- DA018 FDA UDI
- Primary DI / UDI-DI
- 00834061000187 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00834061000187 EUDAMED
- 510(k) Number
- K130324 FDA UDI
- FDA Product Code
- QSY FDA UDI
- EMDN Code
- M040504 INORGANIC HAEMOSTATIC DEVICES EUDAMED
- GMDN Term
- Non-organic haemostatic agent FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.4 Centimeter FDA UDI
StatSeal by Biolife, LLC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00834061000187 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biolife, LLC
- EUDAMED SRN
- US-MF-000008811
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 937c5700-914d-456c-92cd-2f535bd2a6c6 61 fields · synced Jul 15, 2026
- FDA UDI 4ee1725a-d79a-4f23-94c1-40cc15751864 38 fields · synced May 30, 2026