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MAARC HF Gel
EUDAMEDClass I (EU MDR)
Ref 9801/1x2
by Aadi Med Private Limited (Formerly known as Shiva Products)
Identity
- Trade Name
- MAARC HF Gel EUDAMED
- Device Name
- MAARC HF Gel EUDAMED
- Model / Reference
- 9801/1x2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906110443138 EUDAMED
- Basic UDI-DI
- 890611044HG3138XE EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY 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 HF Gel 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 | 890611044HG3138XE | Class I | Active |
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Manufacturer
- EUDAMED SRN
- IN-MF-000020405
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c2d709c8-68d4-4d2e-b938-b9393447bdef 61 fields · synced Oct 6, 2026