Identity
- Trade Name
- HTS EUDAMED
- Device Name
- HAND CONTROL MITT EUDAMED
- Model / Reference
- PSP1113 EUDAMEDHTSPSP1111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681737409575 EUDAMED
- Basic UDI-DI
- 868173740PKONER4 EUDAMED
- Direct Marketing DI
- 08681737409575 EUDAMED
- EMDN Code
- T0199 GLOVES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
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: Radiation shielding apron
Hts by Hts Medikal Tıbbi Malzeme San. Tic.Ltd.Şti. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 868173740PKONER4 | Class I | Active |
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Manufacturer
- Manufacturer
- Hts Medikal Tıbbi Malzeme San. Tic.Ltd.Şti.
- EUDAMED SRN
- TR-MF-000048100
Sources (1)
- EUDAMED c8b959f3-e4a8-4aca-9b61-83313f42b5aa 61 fields · synced Jul 10, 2026