Identity
- Trade Name
- Dental Instrument EUDAMEDFixture Driver (Machine) EUDAMEDSub. Hex. Machine Fixture Driver FDA UDI
- Generic Name
- Dental implant/prosthesis surgical procedure kit FDA UDI
- Device Name
- Fixture Driver (Machine type) EUDAMEDCOWELL® Reusable Surgical Instrument EUDAMED
- Model / Reference
- 2KMMS01S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809471725304 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809471725304 EUDAMED880947172M01RED04T07XX EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Dental implant/prosthesis surgical procedure kit 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dental Instrument by Cowellmedi Co., Ltd — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809471725304 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08809471725304 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cowellmedi Co., Ltd.
- EUDAMED SRN
- KR-MF-000009689
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED 008c9fc6-1531-45c8-b0e6-0b57b76ca6e3 61 fields · synced Jul 12, 2026
- FDA UDI a817069b-b22f-488a-ac6b-3a78c10d795d 32 fields · synced May 30, 2026
- EUDAMED d3175d3d-a93f-431c-b774-6088983b6714 61 fields · synced Jul 12, 2026