Identity
- Trade Name
- Dental Instrument EUDAMEDMini Plus Implant System FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- Impression Coping EUDAMED
- Model / Reference
- AMCI001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809471729661 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809471729661 EUDAMED
- 510(k) Number
- K090049 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dental Instrument by Cowellmedi 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-08809471729661 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cowellmedi Co., Ltd.
- EUDAMED SRN
- KR-MF-000009689
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 3da6ba09-41d3-4064-b3b4-1908cd7046fb 61 fields · synced Jun 20, 2026
- FDA UDI ba34c28d-a26d-4b3e-b6de-d0d8dd6ce393 33 fields · synced May 29, 2026