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StatSeal (EN)

EUDAMED

Class IIa (EU MDR)

Ref DAP629Ref DX627Ref DM625Ref DAR630

by Biolife, LLC

Identity

Trade Name
StatSeal (EN) EUDAMED
Device Name
StatSeal® Advanced Plus Disc EUDAMED
StatSeal® Extra Large Disc EUDAMED
StatSeal® Medium Disc EUDAMED
StatSeal® Advanced RAD Disc EUDAMED
Model / Reference
DAP629 EUDAMED
DX627 EUDAMED
DM625 EUDAMED
DAR630 EUDAMED

Identifiers

Primary DI / UDI-DI
00834061005298 EUDAMED
00834061005274 EUDAMED
00834061005250 EUDAMED
00834061005304 EUDAMED
Basic UDI-DI
0834061005298RM EUDAMED
0834061005274R7 EUDAMED
0834061005250QR EUDAMED
0834061005304QP 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

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Manufacturer

Manufacturer
Biolife, LLC
EUDAMED SRN
US-MF-000008811
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (4)

  • EUDAMED ea328151-5803-4e77-9b23-8f08c8eabf62 61 fields · synced Aug 1, 2026
  • EUDAMED bdafd1c6-d4e0-434f-9ed4-23a4c0f329c6 61 fields · synced May 17, 2026
  • EUDAMED e1a41201-905c-415d-a36a-56d1231ec5e3 61 fields · synced May 18, 2026
  • EUDAMED cf07769e-646d-44ec-9e21-017b51e49c9d 61 fields · synced May 18, 2026