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MAARC Impression compound
EUDAMEDClass I (EU MDR)
Ref 1503/005Model 1501/XXX, 1503/XXX
by Aadi Med Private Limited (Formerly known as Shiva Products)
Identity
- Trade Name
- MAARC Impression compound EUDAMED
- Device Name
- MAARC IMPRESSION COMPOUND EUDAMED
- Model / Reference
- 1501/XXX, 1503/XXX EUDAMED1503/005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906110441004 EUDAMED
- Basic UDI-DI
- 890611044GS119638 EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Silicone dental impression material
MAARC Impression compound by Aadi Med Private Limited (Formerly known as Shiva Products) — Class I — 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 | 890611044GS119638 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- IN-MF-000020405
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 35c17e57-fbcd-41a7-bfcb-2f60f883c242 61 fields · synced Oct 6, 2026