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TMS LINK PLUS Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 24…
EUDAMEDClass IIa (EU MDR)
Ref EL75124
Identity
- Trade Name
- TMS LINK PLUS Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 24 pcs EUDAMED
- Device Name
- TMS Link Plus EUDAMED
- Model / Reference
- EL75124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D661EL751241 EUDAMED
- Basic UDI-DI
- B-D661EL751241 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
TMS LINK PLUS Complete-Kit, Regular Gold, Gold-Plated Stainless Steel, 2in1, 24… by Coltene/Whaledent Inc. — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D661EL751241 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (1)
- EUDAMED 8dcae164-617d-4fd8-98d6-44da6029c4df 61 fields · synced Jun 18, 2026