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Disposable bite trays
EUDAMEDClass I (EU MDR)
Ref #BRTFModel #BRTF #BRTA #BRTQ #BTRP #BRTD #BRSD #IM1-10 #PT #ITT06 #DFTS #DFTM #DFTL #RB6
Identity
- Device Name
- Disposable bite trays EUDAMED
- Model / Reference
- #BRTF #BRTA #BRTQ #BTRP #BRTD #BRSD #IM1-10 #PT #ITT06 #DFTS #DFTM #DFTL #RB6 EUDAMED#BRTF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977522400639 EUDAMED
- Basic UDI-DI
- 697752240DBTEU01SH EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Dental impression tray, single-use
Disposable bite trays by Shanghai Lions Industrial Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental impression tray, single-use.
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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 | 697752240DBTEU01SH | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Lions Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000041956
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9cbf49f3-77bd-4ec1-8904-1fc4c6584ceb 61 fields · synced Aug 1, 2026