Identity
- Trade Name
- OptiFlow II Flowable Composite EUDAMED
- Device Name
- OptiFlow II Flowable Composite EUDAMED
- Model / Reference
- 48212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818746023166 EUDAMED
- Basic UDI-DI
- 081874602480000H7 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental composite resin
OptiFlow II Flowable Composite by The Belport Company, Inc. DBA Gingi-Pak — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 081874602480000H7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- The Belport Company, Inc. DBA Gingi-Pak
- EUDAMED SRN
- US-MF-000044279
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED 1ad31d9d-85c2-47dd-8adc-478dbb9bac50 61 fields · synced Jun 19, 2026