Identity
- Trade Name
- AtriaPak EUDAMED
- Device Name
- Gingival Retraction Cord EUDAMED
- Model / Reference
- 102 EUDAMED104 EUDAMED101 EUDAMED106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800023600643 EUDAMED08800023600667 EUDAMED08800023600636 EUDAMED08800023600681 EUDAMED
- Basic UDI-DI
- 88000236cord-06KM EUDAMED
- Direct Marketing DI
- 08800023600643 EUDAMED08800023600667 EUDAMED08800023600636 EUDAMED08800023600681 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 (4)
- EUDAMED 0d35cb17-192c-4e3f-9ae9-46262605339a 61 fields · synced Jul 30, 2026
- EUDAMED 53c180be-305b-42fa-9762-9687bc9e25dd 61 fields · synced May 17, 2026
- EUDAMED 52183d84-382f-46d7-8d9d-793304806d97 61 fields · synced May 19, 2026
- EUDAMED 5c103520-43fe-4c4f-96d8-fd3e768a3bfe 61 fields · synced May 19, 2026