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Elephant IV

by Zhejiang YiGao Medical Technology Co., Ltd. 73 variants

Ref CPS09550A-EU, CPS10548A-EU, CPS09055A-EU, CPS11550A-EU, CPS11548A-EU, CPS09040A-EU, CPS11048A-EU, CPS09038A-EU, CPS10540A-EU, CPS09050A-EU, CPS11538A-EU, CPS09548A-EU, CPS10042A-EU, CPS09542A-EU, CPS09042A-EU, CPS09552A-EU, CPS11542A-EU, CPS11040A-EU, CPS10052A-EU, CPS10538A-EU, CPS11050B-EU, CPS13038A-EU, CPS12042A-EU, CPS12050A-EU, CPS10548B-EU, CPS12550B-EU, CPS11538B-EU, CPS12042B-EU, CPS12048A-EU, CPS14055A-EU, CPS10550B-EU, CPS14050B-EU, CPS10038B-EU, CPS12055A-EU, CPS13052B-EU, CPS12542B-EU, CPS14052A-EU, CPS13048B-EU, CPS12552B-EU, CPS09540B-EU, CPS09052B-EU, CPS12538A-EU, CPS11048B-EU, CPS12552A-EU, CPS09555B-EU, CPS14040A-EU, CPS11548B-EU, CPS13038B-EU, CPS12038B-EU, CPS12040B-EU, CPS10052B-EU

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69368888CPSA013L Basic UDI-DI Date1 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Disposable intrarenal pressure monitoring ureteral access sheath
Model / Reference
CPS09550A-EU, CPS10548A-EU, CPS09055A-EU, CPS11550A-EU, CPS11548A-EU, CPS09040A-EU, CPS11048A-EU, CPS09038A-EU, CPS10540A-EU, CPS09050A-EU, CPS11538A-EU, CPS09548A-EU, CPS10042A-EU, CPS09542A-EU, CPS09042A-EU, CPS09552A-EU, CPS11542A-EU, CPS11040A-EU, CPS10052A-EU, CPS10538A-EU, CPS11050B-EU, CPS13038A-EU, CPS12042A-EU, CPS12050A-EU, CPS10548B-EU, CPS12550B-EU, CPS11538B-EU, CPS12042B-EU, CPS12048A-EU, CPS14055A-EU, CPS10550B-EU, CPS14050B-EU, CPS10038B-EU, CPS12055A-EU, CPS13052B-EU, CPS12542B-EU, CPS14052A-EU, CPS13048B-EU, CPS12552B-EU, CPS09540B-EU, CPS09052B-EU, CPS12538A-EU, CPS11048B-EU, CPS12552A-EU, CPS09555B-EU, CPS14040A-EU, CPS11548B-EU, CPS13038B-EU, CPS12038B-EU, CPS12040B-EU, CPS10052B-EU
Primary DI / UDI-DI
06937440449776, 06937440449905, 06937440449721, 06937440450055, 06937440450048, 06937440449677, 06937440449974, 06937440449660, 06937440449882, 06937440443354, 06937440450017, 06937440449769, 06937440449820, 06937440449752, 06937440449684, 06937440449783, 06937440450031, 06937440449950, 06937440449851, 06937440449875, 06937440450680, 06937440450222, 06937440450109, 06937440450123, 06937440450604, 06937440450895, 06937440450710, 06937440450802, 06937440450116, 06937440450352, 06937440450611, 06937440451038, 06937440450505, 06937440450147, 06937440450970, 06937440450871, 06937440450345, 06937440450956, 06937440450901, 06937440450444, 06937440450413, 06937440450154, 06937440450673, 06937440450208, 06937440450499, 06937440450307, 06937440450741, 06937440450925, 06937440450789, 06937440450796, 06937440450550
Basic UDI-DI
69368888CPSA013L, 69368888CPSB013R
EMDN Code
U090399 Single-use instruments for urogenital endoscopy - other
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000032913
Authorised representative
TRANSMED GLOBAL CONSULTING, S.L. ES-AR-000044598

Other devices from Zhejiang Yigao Medical Technology Co., Ltd.

See all devices from Zhejiang Yigao Medical Technology Co., Ltd. →

Properties

  • Sterile
  • Measuring Function

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No