Identity
- Trade Name
- ALTECH® EUDAMED
- Device Name
- ALTECH® Vaginal Speculum EUDAMED
- Model / Reference
- 104002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M7121040021 EUDAMED
- Basic UDI-DI
- ++M712104SPECULUM2A EUDAMED
- Direct Marketing DI
- +M7121040021 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE 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
Altech® by Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++M712104SPECULUM2A | Class I | Active |
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Manufacturer
- Manufacturer
- Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000025066
Sources (1)
- EUDAMED 3c4f70fa-5e50-4177-941d-f2f842477e6c 61 fields · synced Oct 6, 2026