Identity
- Trade Name
- 3D-SHAPER EUDAMED
- Device Name
- 3D-SHAPER EUDAMED
- Model / Reference
- 3D-SHAPER EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437021740011 EUDAMED
- Basic UDI-DI
- 84370217403DSHAPERGA EUDAMED
- Direct Marketing DI
- 08437021740011 EUDAMED
- EMDN Code
- Z11900182 BONE DENSITOMETRY SYSTEMS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
3d-Shaper by 3D-Shaper Medical S.L. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220822 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K251022 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 84370217403DSHAPERGA | Class IIa | Active |
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Manufacturer
- Manufacturer
- 3D-Shaper Medical S.L.
- EUDAMED SRN
- ES-MF-000001324
- FDA Applicant
- 3D-Shaper Medical S.L
Sources (2)
- EUDAMED 022663a1-1dc0-43da-9678-d5753e071c59 85 fields · synced Jun 18, 2026
- FDA 510(k) K220822 1 fields · synced May 18, 2026