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Orti̇mplant
EUDAMEDClass I (EU MDR)
Ref OSI150947Model ORTİMPLANT
by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi
Identity
- Trade Name
- ORTİMPLANT EUDAMED
- Device Name
- PINARD STETHOSCOPE WOODEN 145MM EUDAMED
- Model / Reference
- ORTİMPLANT EUDAMEDOSI150947 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680941192532 EUDAMED
- Basic UDI-DI
- 8680941OOTH00001GX EUDAMED
- Direct Marketing DI
- 08680941192532 EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Orti̇mplant by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
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- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- 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 | 8680941OOTH00001GX | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017438
Sources (1)
- EUDAMED 85b7b43e-9667-4598-91e7-a5017c035714 61 fields · synced Jun 20, 2026