Identity
- Trade Name
- Dental Surgical Instrument EUDAMEDDental Surgical Kit FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Screw Kit EUDAMED
- Model / Reference
- KIGICS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016112610 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800016112610 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Dental Surgical Instrument by Cowellmedi Co., Ltd — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800016112610 | 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 23c23f97-64d8-443a-bd12-0ab5b25087ec 61 fields · synced Oct 6, 2026
- FDA UDI f5dfdb54-80d1-48a0-b8a9-56a3e27e1cf6 32 fields · synced May 30, 2026