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Disposable access sheath
EUDAMEDClass IIa (EU MDR)
Ref P10040422Model DYQ-BRef P10040432Ref P10040242Ref P10040232Ref P100404142Ref P10040252Ref P10040442Ref P10040402Ref P10040292Ref P10040462Ref P100402122Ref P100402132Ref P10040492Ref P100404102Ref P10040262Ref P100402102Ref P10040482Ref P10040282
Identity
- Device Name
- Disposable access sheath EUDAMED
- Model / Reference
- DYQ-B EUDAMEDP10040422 EUDAMEDP10040432 EUDAMEDP10040242 EUDAMEDP10040232 EUDAMEDP100404142 EUDAMEDP10040252 EUDAMEDP10040442 EUDAMEDP10040402 EUDAMEDP10040292 EUDAMEDP10040462 EUDAMEDP100402122 EUDAMEDP100402132 EUDAMEDP10040492 EUDAMEDP100404102 EUDAMEDP10040262 EUDAMEDP100402102 EUDAMEDP10040482 EUDAMEDP10040282 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976132632027 EUDAMED06976132632034 EUDAMED06976132631747 EUDAMED06976132631730 EUDAMED06976132632140 EUDAMED06976132631754 EUDAMED06976132632041 EUDAMED06976132632003 EUDAMED06976132631792 EUDAMED06976132632065 EUDAMED06976132631822 EUDAMED06976132631839 EUDAMED06976132632096 EUDAMED06976132632102 EUDAMED06976132631761 EUDAMED06976132631808 EUDAMED06976132632089 EUDAMED06976132631785 EUDAMED
- Basic UDI-DI
- 697613263DYQ003KL EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Disposable access sheath by Hangzhou Hawk Medical Technology 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
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Disposable Ureteral Guide Sheath — Dongguan ZSR Biomedical Technology Company Limited · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.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
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 | 697613263DYQ003KL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Hawk Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000040170
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (18)
- EUDAMED 8b9369e0-b906-460b-8554-92ca67b51ff1 61 fields · synced Aug 1, 2026
- EUDAMED e352548d-c466-49da-8324-b4daa773209e 61 fields · synced May 11, 2026
- EUDAMED ef7725f9-e8c6-4641-ab1e-1f38f03ca71f 61 fields · synced May 16, 2026
- EUDAMED f09ac6d6-40b5-46d6-9793-ec661da7a070 61 fields · synced May 16, 2026
- EUDAMED caf07770-9a86-4b81-b092-4cd7be6c9e5e 61 fields · synced May 16, 2026
- EUDAMED 3090a908-910d-404b-9a56-e0494b320498 61 fields · synced May 17, 2026
- EUDAMED 97e158e2-f9f1-495f-8f6e-d5990b0a6bd3 61 fields · synced May 17, 2026
- EUDAMED f37b3150-2d62-4771-b45e-2966942be536 61 fields · synced May 17, 2026
- EUDAMED fbeac6d1-4d60-4928-ad85-5faaefe2e0bd 61 fields · synced May 17, 2026
- EUDAMED bbae3ab4-6b10-4b8a-a641-5441067ec6bd 61 fields · synced May 17, 2026
- EUDAMED 43bab62d-3f50-45a6-b6ba-243421f36dbf 61 fields · synced May 17, 2026
- EUDAMED 7551e52d-d572-4cbf-909c-dfb7f2690846 61 fields · synced May 18, 2026
- EUDAMED addda247-735c-41cc-8f85-e81f24d0badf 61 fields · synced May 18, 2026
- EUDAMED da140fd7-1e21-40ac-b40a-7c6f02af422b 61 fields · synced May 18, 2026
- EUDAMED 1b9df04a-824e-47ef-a75b-513e0323d9c9 61 fields · synced May 18, 2026
- EUDAMED 46d2c5bf-2d60-4888-b4ab-ae04492f0535 61 fields · synced May 18, 2026
- EUDAMED 18aa0bf2-5c82-4ded-aded-a52394c69120 61 fields · synced May 18, 2026
- EUDAMED 63c6373c-1982-4998-b9ea-e123ee8f22e1 61 fields · synced May 19, 2026