Identity
- Trade Name
- IDOL EUDAMED
- Device Name
- SCALPEL HANDLE 135mm EUDAMED
- Model / Reference
- BS 200-03 EUDAMEDBS 213-08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699241038396 EUDAMED
- Basic UDI-DI
- 86992410TD01-02J3 EUDAMED
- Direct Marketing DI
- 08699241038396 EUDAMED
- EMDN Code
- L1203 LAPAROSCOPIC AND THORACOSCOPIC SURGERY MANIPULATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Surgical instrument handle, non-torque-limiting
Idol by İdol Hastane Ürün. San. Ve Ti̇c. A.ş. — 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 | 86992410TD01-02J3 | Class I | Active |
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Manufacturer
- Manufacturer
- İdol Hastane Ürün. San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000026386
Sources (1)
- EUDAMED d26471fa-a492-43f3-8a2d-3050fb900015 61 fields · synced Jun 19, 2026