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Primacath
EUDAMEDClass IIa (EU MDR)
Ref 2012Model Hydrophilic Urinary Catheter Ring PYU-CH 12-20 CM
by Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
Identity
- Trade Name
- Primacath EUDAMED
- Device Name
- Hydrophilic Urinary Catheter Ring EUDAMED
- Model / Reference
- Hydrophilic Urinary Catheter Ring PYU-CH 12-20 CM EUDAMED2012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680110403940 EUDAMED
- Basic UDI-DI
- B-08680110403940 EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING 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
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: Intermittent urethral drainage catheter, non-antimicrobial, single-use
Primacath by Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- hi-slip plus — Wellspect HealthCare · Class I
- TruCath Oasis — H R Pharmaceuticals, Inc. · Class II
- SmoothCath™ — GELİŞİM MEDİKAL TIBBİ MALZ. PAZ. SAN. VE TİC. LTD. ŞTİ. · Class I
- PVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Class II
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- CompactCath Nelaton, Female, 14 Fr/Ch, 19cm — Lentismed d.o.o. · Class I
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-08680110403940 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000038388
Sources (1)
- EUDAMED 6f0d8677-4155-4fdd-93ef-895f2ae851a5 61 fields · synced Oct 6, 2026