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MAARC Bite Wafers(BRW)
EUDAMEDClass I (EU MDR)
Ref 2210/010Model 2202/XXX, 2207/XXX, 2208/XXX, 2210/XXX, 2213/XXX, 2214/XXX, 2311/XXX
by Aadi Med Private Limited (Formerly known as Shiva Products)
Identity
- Trade Name
- MAARC Bite Wafers(BRW) EUDAMED
- Device Name
- MAARC Bite Registration Wax (all colours) EUDAMED
- Model / Reference
- 2202/XXX, 2207/XXX, 2208/XXX, 2210/XXX, 2213/XXX, 2214/XXX, 2311/XXX EUDAMED2210/010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906110440267 EUDAMED
- Basic UDI-DI
- 890611044BR0298YT EUDAMED
- EMDN Code
- Q01020203 OCCLUSAL WAXES 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
MAARC Bite Wafers(BRW) 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 | 890611044BR0298YT | Class I | Active |
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Manufacturer
- EUDAMED SRN
- IN-MF-000020405
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 2cc69e74-4eb3-470a-b5c7-579edf491374 61 fields · synced Oct 7, 2026