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COWELL® Reusable Surgical Instruments
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 4KCS35
Identity
- Trade Name
- COWELL® Reusable Surgical Instruments EUDAMEDCountersink FDA UDI
- Generic Name
- Dental soft-tissue coring punch, reusable FDA UDI
- Device Name
- Countersink EUDAMED
- Model / Reference
- 4KCS35 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809471725236 EUDAMEDFDA UDI
- Basic UDI-DI
- 880947172M01REA22E07UM EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Dental soft-tissue coring punch, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 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
COWELL® Reusable Surgical Instruments by Cowellmedi Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880947172M01REA22E07UM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 6d73bf5b-7389-4c5b-82fb-c59b668426ea 61 fields · synced Jun 18, 2026
- FDA UDI 45985d2e-ad7f-4b70-a554-2a5633de5a09 32 fields · synced May 30, 2026