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Praveza ® Ureteral Access Sheath
EUDAMEDClass IIa (EU MDR)
Ref BUAB09505500Ref BUAB01102800Ref BUAB01004500Ref BUAB01103500Ref BUAB01202800Ref BUAB09502800
Identity
- Trade Name
- Praveza ® Ureteral Access Sheath EUDAMED
- Device Name
- Ureteral Access Sheath EUDAMED
- Model / Reference
- BUAB09505500 EUDAMEDBUAB01102800 EUDAMEDBUAB01004500 EUDAMEDBUAB01103500 EUDAMEDBUAB01202800 EUDAMEDBUAB09502800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905080008347 EUDAMED08905080049722 EUDAMED08905080046844 EUDAMED08905080049692 EUDAMED08905080008439 EUDAMED08905080008316 EUDAMED
- Basic UDI-DI
- 8905080BUAGS EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Praveza ® Ureteral Access Sheath by Blue Neem Medical Devices Private Limited — 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
- 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8905080BUAGS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Neem Medical Devices Private Limited
- EUDAMED SRN
- IN-MF-000021793
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (6)
- EUDAMED 16409bb6-6db9-4760-9a39-a349b6e448c5 61 fields · synced Aug 4, 2026
- EUDAMED 6c547286-7393-4b9b-bb78-83998ecfb3cf 61 fields · synced May 17, 2026
- EUDAMED 5082dafa-3707-4279-ace6-2804daef9370 61 fields · synced May 17, 2026
- EUDAMED 7aa4a21b-04e5-4a07-bd69-068a6ec44074 61 fields · synced May 18, 2026
- EUDAMED b0bb3d16-f8ac-4844-bfec-50e35104887e 61 fields · synced May 18, 2026
- EUDAMED fc0d6b20-e293-4aad-bafe-257a71433c9b 61 fields · synced May 18, 2026