Identity
- Trade Name
- MAARC Hemostaz Gel - 3g EUDAMED
- Device Name
- Hemostaz Solution - 15 ml EUDAMED
- Model / Reference
- 3016/015 EUDAMED3018/003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906110443114 EUDAMED
- Basic UDI-DI
- 890611044HG3114WY EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS 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 Hemostaz Gel - 3g by Aadi Med Private Limited — 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 | 890611044HG3114WY | Class I | Active |
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Manufacturer
- Manufacturer
- Aadi Med Private Limited
- EUDAMED SRN
- IN-MF-000020405
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 16c998d0-2f86-4301-9e10-6ae47d075ad5 61 fields · synced Jul 8, 2026