Identity
- Device Name
- ORTHODONTIC WAX EUDAMED
- Model / Reference
- DC1007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977624700002 EUDAMED
- Basic UDI-DI
- 697762470DCEU01LF EUDAMED
- EMDN Code
- Q01020203 OCCLUSAL WAXES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDSpain 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 Wax by Guangzhou Guotang Health Industry 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 | 697762470DCEU01LF | Class I | Active |
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Manufacturer
- Manufacturer
- Guangzhou Guotang Health Industry Co., Ltd
- EUDAMED SRN
- CN-MF-000043058
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 7c41caed-2eba-46c9-ab14-123d5f36e37d 61 fields · synced Oct 6, 2026
- EUDAMED 3efd2de3-ebb9-432d-aec0-1ba10a857d70 61 fields · synced Oct 6, 2026