Identity
- Trade Name
- SH01 EUDAMEDSHINING 3D® FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Splint Hard Resin EUDAMEDThe product is used for the fabrication of preformed tooth positioner by dental professionals. FDA UDI
- Model / Reference
- SH01 EUDAMEDFDA UDI0202 EUDAMED
- Description
- The product is used for the fabrication of preformed tooth positioner by dental professionals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975338700202 EUDAMEDFDA UDI
- Basic UDI-DI
- 697533870SH01NM EUDAMED
- Direct Marketing DI
- 06975338700202 EUDAMED
- FDA Product Code
- KMY FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sh01 by Hangzhou SHINING3D Dental Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697533870SH01NM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou SHINING3D Dental Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033456
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 73e0738c-a6d3-4605-b78f-eafc253b162a 61 fields · synced Oct 6, 2026
- FDA UDI 089cc2e8-a752-4d7b-8d0f-9b9ac8717caf 33 fields · synced May 30, 2026