Identity
- Trade Name
- Dental Instrument EUDAMEDFDA UDIHex Driver (Ratchet) EUDAMED
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Hex Driver (Ratchet type) EUDAMEDCOWELL® Reusable Surgical Instrument EUDAMED
- Model / Reference
- KHD1212 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016108729 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800016108729 EUDAMED880947172M01RED04T07XX EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Surgical screwdriver, 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
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
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
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-08800016108729 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800016108729 | 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 (3)
- EUDAMED aa1db877-2e90-4ae1-8e0b-57bee9c11332 61 fields · synced Jun 18, 2026
- FDA UDI 1cc9bd2f-de6a-44b4-bc6a-44bc5818aa55 32 fields · synced May 30, 2026
- EUDAMED 25c3f0d7-4ef8-4e71-8aa7-481ed8641666 61 fields · synced Jun 18, 2026