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Disposable Ureteral Guide Sheath
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ZSR-UAW-1145Model ZSR-UA, ZSR-UAY, ZSR-UAWRef ZSR-UAW-1445ARef ZSR-UAY-1235Ref ZSR-UAC-1035ARef ZSR-UAY-1235ARef ZSR-UA-1235Ref ZSR-UAC-1040ARef ZSR-UAC-0940ARef ZSR-UAY-1045Ref ZSR-UAC-0935ARef ZSR-UAC-1135ARef ZSR-UAY-0940ARef ZSR-UAC-1240ARef ZSR-UAY-1445Ref ZSR-UAC-1340ARef ZSR-UAY-1245Ref ZSR-UAW-1035Ref ZSR-UAC-0950ARef ZSR-UAW-1235ARef ZSR-UAW-1345ARef ZSR-UAW-1045Ref ZSR-UA-1435Ref ZSR-UA-1245ARef ZSR-UAY-1145Ref ZSR-UAY-1435Ref ZSR-UAC-1050ARef ZSR-UAW-1045ARef ZSR-UAW-1235Ref ZSR-UA-1235ARef ZSR-UAC-1045ARef ZSR-UAC-1250ARef ZSR-UAW-1245ARef ZSR-UA-1345Ref ZSR-UA-1435ARef ZSR-UA-1335Ref ZSR-UA-1445ARef ZSR-UAC-1235ARef ZSR-UAY-1335Ref ZSR-UAW-1435Ref ZSR-UAC-1245A
Identity
- Trade Name
- Disposable Ureteral Guide Sheath EUDAMED
- Device Name
- Disposable Ureteral Guide Sheath EUDAMED
- Model / Reference
- ZSR-UA, ZSR-UAY, ZSR-UAW EUDAMEDZSR-UAW-1145 EUDAMEDZSR-UAW-1445A EUDAMEDZSR-UAY-1235 EUDAMEDZSR-UAC-1035A EUDAMEDZSR-UAY-1235A EUDAMEDZSR-UA-1235 EUDAMEDZSR-UAC-1040A EUDAMEDZSR-UAC-0940A EUDAMEDZSR-UAY-1045 EUDAMEDZSR-UAC-0935A EUDAMEDZSR-UAC-1135A EUDAMEDZSR-UAY-0940A EUDAMEDZSR-UAC-1240A EUDAMEDZSR-UAY-1445 EUDAMEDZSR-UAC-1340A EUDAMEDZSR-UAY-1245 EUDAMEDZSR-UAW-1035 EUDAMEDZSR-UAC-0950A EUDAMEDZSR-UAW-1235A EUDAMEDZSR-UAW-1345A EUDAMEDZSR-UAW-1045 EUDAMEDZSR-UA-1435 EUDAMEDZSR-UA-1245A EUDAMEDZSR-UAY-1145 EUDAMEDZSR-UAY-1435 EUDAMEDZSR-UAC-1050A EUDAMEDZSR-UAW-1045A EUDAMEDZSR-UAW-1235 EUDAMEDZSR-UA-1235A EUDAMEDZSR-UAC-1045A EUDAMEDZSR-UAC-1250A EUDAMEDZSR-UAW-1245A EUDAMEDZSR-UA-1345 EUDAMEDZSR-UA-1435A EUDAMEDZSR-UA-1335 EUDAMEDZSR-UA-1445A EUDAMEDZSR-UAC-1235A EUDAMEDZSR-UAY-1335 EUDAMEDZSR-UAW-1435 EUDAMEDZSR-UAC-1245A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345101604 EUDAMED06936345104780 EUDAMED06936345101574 EUDAMED06936345109488 EUDAMED06936345104650 EUDAMED06936345104483 EUDAMED06936345109501 EUDAMED06936345111023 EUDAMED06936345104599 EUDAMED06936345111016 EUDAMED06936345109587 EUDAMED06936345110972 EUDAMED06936345109709 EUDAMED06936345104643 EUDAMED06936345109808 EUDAMED06936345101581 EUDAMED06936345104698 EUDAMED06936345111047 EUDAMED06936345104759 EUDAMED06936345109204 EUDAMED06936345104704 EUDAMED06936345104520 EUDAMED06936345104551 EUDAMED06936345101567 EUDAMED06936345104636 EUDAMED06936345109549 EUDAMED06936345108948 EUDAMED06936345101611 EUDAMED06936345104544 EUDAMED06936345109525 EUDAMED06936345109747 EUDAMED06936345104766 EUDAMED06936345104513 EUDAMED06936345104568 EUDAMED06936345104506 EUDAMED06936345104575 EUDAMED06936345109686 EUDAMED06936345104612 EUDAMED06936345104735 EUDAMED06936345109723 EUDAMED
- Basic UDI-DI
- 69363451ZSRUGS007BM EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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 Ureteral Guide Sheath by Dongguan ZSR Biomedical Technology Company Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 access sheath — Hangzhou Hawk Medical Technology Co., 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
- 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 (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241181 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69363451ZSRUGS007BM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan ZSR Biomedical Technology Company Limited
- EUDAMED SRN
- CN-MF-000016828
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (41)
- EUDAMED 8c75ef37-4cae-4e05-beab-a0e65fca0674 61 fields · synced Sep 17, 2026
- EUDAMED 95b61588-7d90-49af-af52-47ff7b9cf912 61 fields · synced May 11, 2026
- EUDAMED 892c4ff2-dcb9-4634-872b-be4dbb329c80 61 fields · synced May 16, 2026
- EUDAMED d0fba20c-9c40-4ab0-af7c-278b4b90b238 61 fields · synced May 16, 2026
- EUDAMED 88e96d86-ecba-4e60-9c74-ea89d9fe01eb 61 fields · synced May 16, 2026
- EUDAMED f5d4b50e-2abf-48dc-a11c-8865ab54fe2f 61 fields · synced May 16, 2026
- EUDAMED 523518d6-8610-4c84-9747-47fc9723e0cd 61 fields · synced May 16, 2026
- EUDAMED 9c631af1-c129-40e5-bbb7-1f1edfdb09e8 61 fields · synced May 16, 2026
- EUDAMED dfdaa4cb-2202-4504-b7f4-942379d9b118 61 fields · synced May 16, 2026
- EUDAMED 7f99b4be-f8f5-4bc8-a43b-be6894fdbe70 61 fields · synced May 17, 2026
- EUDAMED d88829c1-580c-4e54-9ac3-34df4d22afc8 61 fields · synced May 17, 2026
- EUDAMED af3943ba-203c-4e00-b7c2-e641b878e8c0 61 fields · synced May 17, 2026
- EUDAMED f864c8df-30c6-4aef-8891-d17788300d25 61 fields · synced May 17, 2026
- EUDAMED 896c878c-df82-4a10-a687-504d5c77eca6 61 fields · synced May 17, 2026
- EUDAMED 0277a697-84ce-4c02-9df4-f823b05ec6fb 61 fields · synced May 17, 2026
- EUDAMED b92a1001-7f70-4d23-ac6a-6e9d708ab9d2 61 fields · synced May 17, 2026
- EUDAMED bc64944b-bed1-45ea-89bd-f01266dfbc5e 61 fields · synced May 17, 2026
- EUDAMED 16c75e95-e3a1-45f1-b586-014a3cc40efc 61 fields · synced May 17, 2026
- EUDAMED 4037cb0a-5fc5-45e7-b7bf-0d81bb868d78 61 fields · synced May 17, 2026
- EUDAMED f1435a9e-988d-469a-a464-3775ec0bf789 61 fields · synced May 17, 2026
- EUDAMED f84ef2d4-894a-412f-a59e-5e82c98d5ef6 61 fields · synced May 17, 2026
- EUDAMED f36ed742-f185-4416-8f95-a877f476571b 61 fields · synced May 18, 2026
- EUDAMED 447780be-7e3a-4a73-aaea-d81b9b9bdb35 61 fields · synced May 18, 2026
- EUDAMED 347b0e6f-eabd-4500-8c6a-121bb1830ba4 61 fields · synced May 18, 2026
- EUDAMED 3e27a0b6-e1ec-4a2f-884d-6d5dc1134e5e 61 fields · synced May 18, 2026
- EUDAMED df0c7c30-b6d1-487c-9afe-f94be7393635 61 fields · synced May 18, 2026
- EUDAMED 678837dd-9ee1-4f1c-bc7a-b82ba8351ffe 61 fields · synced May 18, 2026
- EUDAMED f752ec60-2572-4b0a-a8e7-491ad226744b 61 fields · synced May 18, 2026
- EUDAMED 1e33089d-192e-4e5c-8d92-b6bc5dccee76 61 fields · synced May 18, 2026
- EUDAMED a7460f6c-dc1e-44b4-9f21-c0dbb380a45b 61 fields · synced May 18, 2026
- EUDAMED 394611c8-4cd8-4048-a16f-c262f07c6543 61 fields · synced May 18, 2026
- EUDAMED 5b40bdd3-cd76-4d1e-b9be-e744c94fa8df 61 fields · synced May 18, 2026
- EUDAMED 33a14557-c791-4c81-bbde-a008affd4456 61 fields · synced May 18, 2026
- EUDAMED a44a7f4e-513c-45bc-a73f-b4d996ef6a21 61 fields · synced May 18, 2026
- EUDAMED 98bcdf48-f897-4cf7-8929-e676b4c004c7 61 fields · synced May 18, 2026
- EUDAMED ab8ad007-0de5-4c6a-8bcf-254c8bd7a2d8 61 fields · synced May 18, 2026
- EUDAMED 1e6d8c47-f0c4-4576-8edf-a454871d8c44 61 fields · synced May 18, 2026
- EUDAMED fe9928e1-b148-4a37-9d75-203b41bac45d 61 fields · synced May 18, 2026
- EUDAMED b50b6832-16b8-48ad-8d76-ee834b966482 61 fields · synced May 19, 2026
- EUDAMED 3572a393-7f70-4c01-8134-80374b2e9f21 61 fields · synced May 19, 2026
- FDA 510(k) K241181 1 fields · synced May 18, 2026