Identity
- Trade Name
- Pro-Form Splint Material EUDAMED
- Device Name
- Splint Material EUDAMED
- Model / Reference
- 9614860R1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++H6689614860R11 EUDAMED
- Basic UDI-DI
- B-++H6689614860R11 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Pro-Form Splint Material by Keystone Industries — Class I — 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-++H6689614860R11 | Class I | Active |
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Manufacturer
- Manufacturer
- Keystone Industries
- EUDAMED SRN
- US-MF-000020203
- Authorised Representative
- KEYSTONE Europe BV NL-AR-000010443
Sources (1)
- EUDAMED 9afcfa78-c295-4fa6-9dc6-3dba245104e9 61 fields · synced Jul 27, 2026