Identity
- Trade Name
- AtriaPak EUDAMED
- Device Name
- Gingival Retraction Cord EUDAMED
- Model / Reference
- 103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800023600650 EUDAMED
- Basic UDI-DI
- 88000236cord-06KM EUDAMED
- Direct Marketing DI
- 08800023600650 EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
AtriaPak by Atria Co. — 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 | 88000236cord-06KM | Class I | Active |
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Manufacturer
- Manufacturer
- Atria Co.
- EUDAMED SRN
- KR-MF-000036351
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 4cc6ecc8-fee2-47ff-996f-46e06697a79c 61 fields · synced Jun 18, 2026