Identity
- Trade Name
- Ø46 Bipolar Trial Cup EUDAMED
- Model / Reference
- TRIALS EUDAMEDTHR106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682549591397 EUDAMED
- Basic UDI-DI
- 86804870TLHT EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER 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 retraction system, reusable
Ø46 Bipolar Trial Cup by Normmed Medi̇kal San. Ve Ti̇c. A.ş. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical retraction system, reusable.
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- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
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 | 86804870TLHT | Class I | Active |
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Manufacturer
- Manufacturer
- Normmed Medi̇kal San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000015713
Sources (1)
- EUDAMED 2b1162dd-8925-42b6-95b8-f6744b9d7b44 61 fields · synced Aug 3, 2026