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aligner chewies & aligner remover
EUDAMEDClass I (EU MDR)
Ref GT2511-1Model GT2511-1/GT2511-2 Ref GT2511-2
Identity
- Device Name
- aligner chewies & aligner remover EUDAMED
- Model / Reference
- GT2511-1/GT2511-2 EUDAMEDGT2511-1 EUDAMEDGT2511-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977624700026 EUDAMED06977624700033 EUDAMED
- Basic UDI-DI
- 697762470ACAR001M5 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDTürkiye 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
aligner chewies & aligner remover 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 | 697762470ACAR001M5 | 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 (3)
- EUDAMED 6e1bc0d6-4a47-4aa0-871a-562a6be4e30a 61 fields · synced Oct 6, 2026
- EUDAMED 775564bd-df42-47d6-a6af-c9378b0f549b 61 fields · synced Jul 9, 2026
- EUDAMED 05162446-ff82-475f-9e78-5109fc108726 61 fields · synced Jul 25, 2026