Identity
- Trade Name
- KeySplint Soft Blue EUDAMED
- Device Name
- 3D Resin for printing soft splints EUDAMED
- Model / Reference
- 4220175 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++H66842201751 EUDAMED
- Basic UDI-DI
- B-++H66842201751 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
KeySplint Soft Blue by Keystone Industries — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-++H66842201751 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Keystone Industries
- EUDAMED SRN
- US-MF-000020203
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED b3accfa6-e972-4aee-9521-1fc703ce80fb 61 fields · synced Jun 11, 2026