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Sh-43b
EUDAMEDClass I (EU MDR)
Ref 9799Model 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
Identity
- Trade Name
- SH-43B 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 EUDAMED9799 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970163089799 EUDAMED
- Basic UDI-DI
- 697016308ScanbodyNP EUDAMED
- Direct Marketing DI
- 06970163089799 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Sh-43b by Shining 3D Tech 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 | 697016308ScanbodyNP | Class I | Active |
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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 (1)
- EUDAMED 1bdfa0c9-a45f-4ce9-b1fa-3e6a7e970af5 61 fields · synced Jul 11, 2026