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OptiFlow II Flowable Composite
EUDAMEDClass IIa (EU MDR)
Ref 48209Ref 48216Ref 48215Ref 48205Ref 48217Ref 48222Ref 48210Ref 48202Ref 48221Ref 48204
Identity
- Trade Name
- OptiFlow II Flowable Composite EUDAMED
- Device Name
- OptiFlow II Flowable Composite EUDAMED
- Model / Reference
- 48209 EUDAMED48216 EUDAMED48215 EUDAMED48205 EUDAMED48217 EUDAMED48222 EUDAMED48210 EUDAMED48202 EUDAMED48221 EUDAMED48204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818746023135 EUDAMED00818746024682 EUDAMED00818746024675 EUDAMED00818746023104 EUDAMED00818746024699 EUDAMED00818746024750 EUDAMED00818746023142 EUDAMED00818746023074 EUDAMED00818746024743 EUDAMED00818746023098 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 (10)
- EUDAMED ab927909-ceb2-4484-8f73-06cd1678136d 61 fields · synced Aug 3, 2026
- EUDAMED 793664e5-f049-4132-aec9-4f0ee1e232b8 61 fields · synced May 16, 2026
- EUDAMED bafe7aaa-611c-4f3e-a4c2-eb1a5aa0c24d 61 fields · synced May 17, 2026
- EUDAMED dd2eb089-a132-40bf-addc-938f68ce8cf9 61 fields · synced May 17, 2026
- EUDAMED 341139b6-a0af-4544-a9fa-0c14d0ebb7c0 61 fields · synced May 17, 2026
- EUDAMED f6030188-989d-4d3a-8847-5a3cfea1c47d 61 fields · synced May 18, 2026
- EUDAMED 29b82cbf-a1e2-4cf6-96dc-e3081f841847 61 fields · synced May 18, 2026
- EUDAMED 0cd9bc43-728b-4c12-98df-4053261f4c27 61 fields · synced May 18, 2026
- EUDAMED 7b062089-884b-4f15-a298-34ff5d1743c0 61 fields · synced May 18, 2026
- EUDAMED 82e7e891-61df-4fa8-b5c0-8239c87487f3 61 fields · synced May 18, 2026