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E-connect S
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 6080051Model E-connect S510(k) K201993Ref 6080258Model E-connect S+
Identity
- Trade Name
- E-connect S EUDAMEDE-connect S+ EUDAMED
- Device Name
- Dental Root Canal Measuring and Treatment Unit EUDAMED
- Model / Reference
- E-connect S EUDAMED6080051 EUDAMEDE-connect S+ EUDAMED6080258 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972597780617 EUDAMED06941877800345 EUDAMED
- Basic UDI-DI
- B-06972597780617 EUDAMED697259778EE003KU EUDAMED
- Direct Marketing DI
- 06941877800345 EUDAMED
- 510(k) Number
- K201993 FDA 510(k)
- FDA Product Code
- EKX FDA 510(k)
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4200 FDA 510(k)
- Regulation Number
- 872.4200 FDA 510(k)
- Market of Registration
- Romania EUDAMEDBulgaria EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental delivery system
E-connect S by Changzhou Sifary Medical Technology Co., Ltd. — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06972597780617 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K201993 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06972597780617 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (3)
- EUDAMED f212160a-9957-4d40-97f2-4152a004b19c 61 fields · synced Aug 4, 2026
- FDA 510(k) K201993 24 fields · synced May 18, 2026
- EUDAMED 300ceaac-4cf2-4853-9010-fca85fc7e3ac 61 fields · synced Jun 20, 2026