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Single-use Ureteral Access Sheath

EUDAMED

Class IIa (EU MDR)

Ref UB-1335Model UB-(1025,1035,1040,1045,1050,1055,1125,1135,1140,1145,1150,1155,1225,1235,1240,UB-1245,UB-1250,UB-1255,UB-1325,UB-1335,UB-1340,UB-1345,UB-1350,UB-1355,UB-1425,UB-1435,UB-1440,UB-1445,UB-1450,UB-1455)

by Scivita Medical Technology Co., Ltd.

Identity

Trade Name
Single-use Ureteral Access Sheath EUDAMED
Device Name
Single-use Ureteral Access Sheath EUDAMED
Model / Reference
UB-(1025,1035,1040,1045,1050,1055,1125,1135,1140,1145,1150,1155,1225,1235,1240,UB-1245,UB-1250,UB-1255,UB-1325,UB-1335,UB-1340,UB-1345,UB-1350,UB-1355,UB-1425,UB-1435,UB-1440,UB-1445,UB-1450,UB-1455) EUDAMED
UB-1335 EUDAMED

Identifiers

Primary DI / UDI-DI
06971381257489 EUDAMED
Basic UDI-DI
697138125045A8X EUDAMED
Direct Marketing DI
06971381257489 EUDAMED
EMDN Code
U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Belgium 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

Single-use Ureteral Access Sheath by Scivita Medical Technology Co., Ltd. — 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
Scivita Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000010305
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED e7141129-9f6e-44b6-81b3-1c2b461b8682 61 fields · synced Jun 18, 2026