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Single-use Ureteral Access Sheath

EUDAMED

Class IIa (EU MDR)

Ref UB-1050Model 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)Ref UA-1045Model UA-（1025、1035、1045、1125、1135、1145、1225、1235、1245、1325、1335、1345、1425、1435、1445）Ref UA-1145Ref UA-1335Ref UB-1445Ref UB-1035Ref UA-1245Ref UB-1340Ref UB-1255Ref UB-1325Ref UA-1035Ref UB-1440Ref UB-1125Ref UB-1025Ref UB-1350Ref UB-1235Ref UB-1150Ref UA-1445Ref UB-1155Ref UB-1345Ref UB-1145Ref UA-1225Ref UB-1435

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-1050 EUDAMED
UA-（1025、1035、1045、1125、1135、1145、1225、1235、1245、1325、1335、1345、1425、1435、1445） EUDAMED
UA-1045 EUDAMED
UA-1145 EUDAMED
UA-1335 EUDAMED
UB-1445 EUDAMED
UB-1035 EUDAMED
UA-1245 EUDAMED
UB-1340 EUDAMED
UB-1255 EUDAMED
UB-1325 EUDAMED
UA-1035 EUDAMED
UB-1440 EUDAMED
UB-1125 EUDAMED
UB-1025 EUDAMED
UB-1350 EUDAMED
UB-1235 EUDAMED
UB-1150 EUDAMED
UA-1445 EUDAMED
UB-1155 EUDAMED
UB-1345 EUDAMED
UB-1145 EUDAMED
UA-1225 EUDAMED
UB-1435 EUDAMED

Identifiers

Primary DI / UDI-DI
06971381257366 EUDAMED
06971381251708 EUDAMED
06971381257311 EUDAMED
06971381257335 EUDAMED
06971381252712 EUDAMED
06971381252644 EUDAMED
06971381251739 EUDAMED
06971381257496 EUDAMED
06971381257465 EUDAMED
06971381257472 EUDAMED
06971381251692 EUDAMED
06971381257533 EUDAMED
06971381257380 EUDAMED
06971381252637 EUDAMED
06971381257519 EUDAMED
06971381252675 EUDAMED
06971381257427 EUDAMED
06971381251760 EUDAMED
06971381257434 EUDAMED
06971381257502 EUDAMED
06971381257410 EUDAMED
06971381251715 EUDAMED
06971381252705 EUDAMED
Basic UDI-DI
697138125045A8X EUDAMED
697138125021A89 EUDAMED
Direct Marketing DI
06971381257366 EUDAMED
06971381251708 EUDAMED
06971381257311 EUDAMED
06971381257335 EUDAMED
06971381252712 EUDAMED
06971381252644 EUDAMED
06971381251739 EUDAMED
06971381257496 EUDAMED
06971381257465 EUDAMED
06971381257472 EUDAMED
06971381251692 EUDAMED
06971381257533 EUDAMED
06971381257380 EUDAMED
06971381252637 EUDAMED
06971381257519 EUDAMED
06971381252675 EUDAMED
06971381257427 EUDAMED
06971381251760 EUDAMED
06971381257434 EUDAMED
06971381257502 EUDAMED
06971381257410 EUDAMED
06971381251715 EUDAMED
06971381252705 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 (23)

  • EUDAMED dc21fcd8-697e-443f-a21b-5bbe55d78e56 61 fields · synced Sep 18, 2026
  • EUDAMED ac34829d-bea1-4750-b0d9-598fbfb574e9 61 fields · synced May 16, 2026
  • EUDAMED 312b0f93-0ee7-4971-ae71-37dd62f88977 61 fields · synced May 16, 2026
  • EUDAMED f47821ef-4a58-49f2-8671-496dd3d21ac3 61 fields · synced May 16, 2026
  • EUDAMED 55e1a573-c2c5-4b03-aaf2-b1c44ae57cfc 61 fields · synced May 17, 2026
  • EUDAMED a1d95a40-286f-469b-b16b-12cc687b4ee2 61 fields · synced May 17, 2026
  • EUDAMED 4ab0e36b-4a52-4605-97a9-d44c20ddd84e 61 fields · synced May 17, 2026
  • EUDAMED 3be9941e-2638-48f6-a6fa-40fb63afccdc 61 fields · synced May 17, 2026
  • EUDAMED c717a200-bd86-4b35-b8cc-2abc07482895 61 fields · synced May 17, 2026
  • EUDAMED 59da7bfa-cb15-4a54-a69a-396d546fbcec 61 fields · synced May 17, 2026
  • EUDAMED 6dfb63c4-7df8-4f8c-aeff-0d2a3c622099 61 fields · synced May 17, 2026
  • EUDAMED a703e693-a90e-41f6-a3d3-14c441bac504 61 fields · synced May 18, 2026
  • EUDAMED 0476ebf1-5765-4b5b-aefe-7385b3b90f74 61 fields · synced May 18, 2026
  • EUDAMED d8cff6d9-a4bb-47ef-8e28-3c9de4497687 61 fields · synced May 18, 2026
  • EUDAMED f6afc224-814a-48f6-a86d-d20e75a2368e 61 fields · synced May 18, 2026
  • EUDAMED aea7fd13-188f-41d3-9221-60cec4187994 61 fields · synced May 18, 2026
  • EUDAMED c7263e50-e167-4d98-9051-d8f14cd658e8 61 fields · synced May 18, 2026
  • EUDAMED 668b242e-db2b-46e9-b9d2-d92c6b9f4158 61 fields · synced May 19, 2026
  • EUDAMED 181bc1d9-0a42-4eab-a013-648bdd067994 61 fields · synced May 19, 2026
  • EUDAMED 211328a1-0783-4520-8c44-65a2cf50aceb 61 fields · synced May 19, 2026
  • EUDAMED 09a86671-5d2a-45a3-9c31-09133bd67d04 61 fields · synced May 19, 2026
  • EUDAMED 86b0e719-95e8-45e7-9f7b-2bd89e1342d6 61 fields · synced May 19, 2026
  • EUDAMED 08793031-8b90-4679-9895-d0c2f7ccd3bb 61 fields · synced May 19, 2026