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Ureteral Access Sheath
EUDAMEDClass IIa (EU MDR)
Ref H04-1035Model straight typeRef H04-9.535Ref H04-Y1345Model Y typeRef H04-1428Ref H04-9.520Ref H04-Y1245Ref H04-Y1128Ref H04-Y1320Ref H04-Y1455Ref H04-Y1428Ref H04-1128Ref H04-1045Ref H04-Y1120Ref H04-Y1028Ref H04-Y9.545Ref H04-1020Ref H04-Y1135Ref H04-Y1335Ref H04-1328Ref H04-1445Ref H04-Y1055Ref H04-1355Ref H04-Y1113Ref H04-Y1355Ref H04-Y1255Ref H04-Y9.520Ref H04-Y1420Ref H04-9.555Ref H04-Y1445Ref H04-9.528Ref H04-Y1228Ref H04-Y1035
Identity
- Trade Name
- Ureteral Access Sheath EUDAMED
- Device Name
- Ureteral Access Sheath EUDAMED
- Model / Reference
- straight type EUDAMEDH04-1035 EUDAMEDH04-9.535 EUDAMEDY type EUDAMEDH04-Y1345 EUDAMEDH04-1428 EUDAMEDH04-9.520 EUDAMEDH04-Y1245 EUDAMEDH04-Y1128 EUDAMEDH04-Y1320 EUDAMEDH04-Y1455 EUDAMEDH04-Y1428 EUDAMEDH04-1128 EUDAMEDH04-1045 EUDAMEDH04-Y1120 EUDAMEDH04-Y1028 EUDAMEDH04-Y9.545 EUDAMEDH04-1020 EUDAMEDH04-Y1135 EUDAMEDH04-Y1335 EUDAMEDH04-1328 EUDAMEDH04-1445 EUDAMEDH04-Y1055 EUDAMEDH04-1355 EUDAMEDH04-Y1113 EUDAMEDH04-Y1355 EUDAMEDH04-Y1255 EUDAMEDH04-Y9.520 EUDAMEDH04-Y1420 EUDAMEDH04-9.555 EUDAMEDH04-Y1445 EUDAMEDH04-9.528 EUDAMEDH04-Y1228 EUDAMEDH04-Y1035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942214107790 EUDAMED06942214107738 EUDAMED06942214108353 EUDAMED06942214108032 EUDAMED06942214107714 EUDAMED06942214108292 EUDAMED06942214108216 EUDAMED06942214108322 EUDAMED06942214108421 EUDAMED06942214108391 EUDAMED06942214107844 EUDAMED06942214107806 EUDAMED06942214108209 EUDAMED06942214108155 EUDAMED06942214108117 EUDAMED06942214107776 EUDAMED06942214108223 EUDAMED06942214108346 EUDAMED06942214107967 EUDAMED06942214108056 EUDAMED06942214108186 EUDAMED06942214107998 EUDAMED06942214108193 EUDAMED06942214108360 EUDAMED06942214108308 EUDAMED06942214108087 EUDAMED06942214108384 EUDAMED06942214107752 EUDAMED06942214108414 EUDAMED06942214107721 EUDAMED06942214108278 EUDAMED06942214108162 EUDAMED
- Basic UDI-DI
- 697197678DXACE0301VN EUDAMED697197678DXACE0302VQ EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Category: Ureteral introduction sheath
Ureteral Access Sheath by Chengdu Daxan Innovative Medical Tech.Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral introduction sheath.
- Manawa Access Sheath — ENVASTE LTD · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Disposable Ureteral Guide Sheath — Dongguan ZSR Biomedical Technology Company Limited · Class IIa
- Disposable access sheath — Hangzhou Hawk Medical Technology Co., Ltd · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Praveza ® Ureteral Access Sheath — Blue Neem Medical Devices Private Limited · Class IIa
- Single Use Ureteral Access Sheath — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697197678DXACE0301VN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chengdu Daxan Innovative Medical Tech.Co., Ltd
- EUDAMED SRN
- CN-MF-000033805
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (32)
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- EUDAMED 68231989-7ff3-44ee-aa6c-90b27c53c404 61 fields · synced May 17, 2026
- EUDAMED 1f3fefac-ef1f-48c0-9158-7e6fc4aee0e6 61 fields · synced May 17, 2026
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- EUDAMED 8c3ce8ec-534e-4229-8a77-2d4357d601a5 61 fields · synced May 18, 2026
- EUDAMED 40d62971-db3f-421e-8c0f-24c681c0b406 61 fields · synced May 18, 2026
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- EUDAMED 7582b4a3-1825-4131-b014-ada9edc0ac5a 61 fields · synced May 19, 2026
- EUDAMED 72ede1a2-404d-4eef-b45c-75cd87cc6c5a 61 fields · synced May 19, 2026