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Hydrotouch
EUDAMEDClass IIa (EU MDR)
Ref HYT-011Model HYDROTOUCH Sterile Water Soluble Lubricating Gel - 11mL 25pcs/box
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- HYDROTOUCH EUDAMED
- Device Name
- HYDROTOUCH Sterile Water Soluble Lubricating Gel - 11mL EUDAMED
- Model / Reference
- HYDROTOUCH Sterile Water Soluble Lubricating Gel - 11mL 25pcs/box EUDAMEDHYT-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18698703339030 EUDAMED
- Basic UDI-DI
- B-18698703339030 EUDAMED
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER 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
Hydrotouch by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-18698703339030 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 1a25eb7c-4d2b-45b9-88c8-841eb47a04dc 61 fields · synced Oct 7, 2026