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MAARC Gingival Barrier
EUDAMEDClass I (EU MDR)
Ref 8804/003
by Aadi Med Private Limited (Formerly known as Shiva Products)
Identity
- Trade Name
- MAARC Gingival Barrier EUDAMED
- Device Name
- MAARC Gingival Barrier EUDAMED
- Model / Reference
- 8804/003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906110444005 EUDAMED
- Basic UDI-DI
- 890611044GB4005UV EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MAARC Gingival Barrier by Aadi Med Private Limited (Formerly known as Shiva Products) — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 890611044GB4005UV | Class I | Active |
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Manufacturer
- EUDAMED SRN
- IN-MF-000020405
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 211e817a-add3-4ebe-bee9-0729412f8127 61 fields · synced Jun 19, 2026