Identity
- Trade Name
- Orthodontic Gel Blocks EUDAMED
- Device Name
- Orthodontic Gel Blocks EUDAMED
- Model / Reference
- ZJNJ EUDAMEDYC-ZJNJ-007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978785665070 EUDAMED
- Basic UDI-DI
- 6978785662507MT EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Orthodontic Gel Blocks by Shenzhen Yuechuan Trade Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6978785662507MT | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yuechuan trade Co., Ltd.
- EUDAMED SRN
- CN-MF-000048151
- Authorised Representative
- WISELINK MEDICAL, S.L.U. ES-AR-000052118
Sources (1)
- EUDAMED d3072163-7fac-44c5-9825-d434a7056169 61 fields · synced Jun 19, 2026