Identity
- Trade Name
- Abiding Couple Impression Coping EUDAMEDCOUPLE IMPRESSION COPING PICK-UP FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- Abiding Couple Impression Coping EUDAMED
- Model / Reference
- ACIPH-65L EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020804570 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800020804570 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Abiding Couple Impression Coping by SNUCONE Co., LTD. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800020804570 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Snucone Co., Ltd.
- EUDAMED SRN
- KR-MF-000036358
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 6db2497c-676a-407b-b9a8-d3cd498a9cf5 61 fields · synced Jul 21, 2026
- FDA UDI 3f0c07a8-3da3-4ef9-bd08-381b76f0e05b 33 fields · synced May 30, 2026