← Back to catalogue
Disposable Ureteral Access Sheaths
EUDAMEDClass IIa (EU MDR)
Ref 1010Model ZRH-NQG-9.5/10/11/12/14-130/280/350/400/450/500/600-(Y)
Identity
- Trade Name
- Disposable Ureteral Access Sheaths EUDAMED
- Device Name
- Disposable Ureteral Access Sheaths EUDAMED
- Model / Reference
- ZRH-NQG-9.5/10/11/12/14-130/280/350/400/450/500/600-(Y) EUDAMED1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-6979246722GD EUDAMED
- Basic UDI-DI
- B-6979246722GD EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ureteral introduction sheath
Disposable Ureteral Access Sheaths by Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. — Class IIa — MDD — 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
- 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
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-6979246722GD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000027760
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED e56f1931-0598-4e02-8acd-c6e70cf1b57d 61 fields · synced Jun 19, 2026