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Sh-48a
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8143Model HACS-A15-1，HACS-A15-2，HACS-A15-3，HACS-A15-4，HACS-A15-5，HACS-A20-1，HACS-A20-2，HACS-A20-3，HACS-A20-4，HACS-A20-5，HACS-A25-1，HACS-A25-2，HACS-A25-3，HACS-A25-4，HACS-A25-5Ref 9614Model CS-B48-A\CS-B48-B\CS-B48-C\CS-B48-D\CS-B48-E\CS-B48-F\CS-B48-G\CS-B48-H\CS-B48-I\CS-B48-J\CS-B48-K\CS-B48-L
Identity
- Trade Name
- SH-48A EUDAMEDSHINING 3D® FDA UDI
- Generic Name
- Dental implant abutment analog, laboratory FDA UDI
- Device Name
- Scanbody EUDAMED
- Model / Reference
- HACS-A15-1，HACS-A15-2，HACS-A15-3，HACS-A15-4，HACS-A15-5，HACS-A20-1，HACS-A20-2，HACS-A20-3，HACS-A20-4，HACS-A20-5，HACS-A25-1，HACS-A25-2，HACS-A25-3，HACS-A25-4，HACS-A25-5 EUDAMED8143 EUDAMEDCS-B48-A\CS-B48-B\CS-B48-C\CS-B48-D\CS-B48-E\CS-B48-F\CS-B48-G\CS-B48-H\CS-B48-I\CS-B48-J\CS-B48-K\CS-B48-L EUDAMED9614 EUDAMEDSH-48A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970163088143 EUDAMEDFDA UDI06970163089614 EUDAMED
- Basic UDI-DI
- 697016308ScanbodyNP EUDAMED697016308HAFSIFTMR EUDAMED
- Direct Marketing DI
- 06970163088143 EUDAMED06970163089614 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant abutment analog, laboratory FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Sh-48a by Shining 3D Tech 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 | 697016308ScanbodyNP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shining 3D Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008402
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED f04df078-8756-456a-a915-b357bb1c2a28 61 fields · synced Jul 25, 2026
- EUDAMED 7cdcdb12-c8ab-4c5b-8a7b-2661d9853d0d 61 fields · synced May 18, 2026
- FDA UDI 614374d0-0e3a-4c38-b422-da84d183f9f3 32 fields · synced May 30, 2026