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Manawa Access Sheath
EUDAMEDClass IIa (EU MDR)
Ref UAS-0110728SModel Manawa Access Sheath Ref UAS-0114028SRef UAS-0114020SRef UAS-0109528SRef UAS-0114035SRef UAS-0110745SRef UAS-0112028SRef UAS-0110720S
by Envaste Ltd
Identity
- Trade Name
- Manawa Access Sheath EUDAMED
- Device Name
- Manawa Access Sheath EUDAMED
- Model / Reference
- Manawa Access Sheath EUDAMEDUAS-0110728S EUDAMEDUAS-0114028S EUDAMEDUAS-0114020S EUDAMEDUAS-0109528S EUDAMEDUAS-0114035S EUDAMEDUAS-0110745S EUDAMEDUAS-0112028S EUDAMEDUAS-0110720S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60913190403006 EUDAMED60913190403860 EUDAMED60913190403792 EUDAMED60913190402634 EUDAMED60913190403938 EUDAMED60913190403242 EUDAMED60913190403488 EUDAMED60913190402948 EUDAMED
- Basic UDI-DI
- 60913190UASWF EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Manawa Access Sheath by Envaste Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral introduction sheath.
- 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
- 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 | 60913190UASWF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Envaste Ltd
- EUDAMED SRN
- MU-MF-000030801
- Authorised Representative
- ENVASTE LTD IE-AR-000028866
Sources (8)
- EUDAMED 79508260-cca0-441a-9f5e-eb5b39fda773 61 fields · synced Jul 28, 2026
- EUDAMED ad10ada7-6ceb-4341-b334-5bf2dd8ab394 61 fields · synced May 17, 2026
- EUDAMED cf16fa18-4437-47c3-9757-5c3294242bed 61 fields · synced May 17, 2026
- EUDAMED 7203d0b6-d20a-4905-8946-18504ce60b45 61 fields · synced May 17, 2026
- EUDAMED 368acbc2-b876-4cc5-b688-ad52a12d928e 61 fields · synced May 17, 2026
- EUDAMED 39f981da-30d2-4b9a-972b-d9e80356f854 61 fields · synced May 17, 2026
- EUDAMED 093ecbb3-5e29-4c2c-ae9c-935d47656641 61 fields · synced May 18, 2026
- EUDAMED aa51cd9f-2f70-490c-b253-b89ba3ecb061 61 fields · synced May 19, 2026