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Dental Instrument
EUDAMEDFDA UDIClass I (EU MDR)
Ref MEW002Ref ADRFD01LRef 2SSFI3835CRef 2SSHR100SRef RSM001Ref SIS001SN
Identity
- Trade Name
- Dental Instrument EUDAMEDDental Implants Accesseories-Single Use FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Fixture Mount EUDAMEDADD Fixture Driver(Machine) EUDAMEDImpression coping EUDAMEDScanbody Screw EUDAMEDPick-up Guide Pin EUDAMED
- Model / Reference
- MEW002 EUDAMEDADRFD01L EUDAMED2SSFI3835C EUDAMEDFDA UDI2SSHR100S EUDAMEDRSM001 EUDAMEDSIS001SN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800016112757 EUDAMED08800016112313 EUDAMED08800016109894 EUDAMEDFDA UDI08800016113877 EUDAMED08800016104295 EUDAMED08800016105155 EUDAMED
- Basic UDI-DI
- B-08800016112757 EUDAMEDB-08800016112313 EUDAMEDB-08800016109894 EUDAMEDB-08800016113877 EUDAMEDB-08800016104295 EUDAMEDB-08800016105155 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMEDP01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental impression tray, single-use 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
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
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
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 — 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-08800016112757 | 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 (7)
- EUDAMED 0520bcc3-ab5a-4b40-bc23-90db4029d0f8 61 fields · synced Jul 22, 2026
- EUDAMED ae362fe2-8a79-40ab-84f6-852d6bec06b3 61 fields · synced May 16, 2026
- EUDAMED 7510cd93-d752-4ea5-87e0-c12efd1107e0 61 fields · synced May 16, 2026
- EUDAMED 2abbe30a-b440-4531-ac37-8b721481fd45 61 fields · synced May 18, 2026
- EUDAMED 02dfc31d-1f36-4ac4-a003-e352666f5922 61 fields · synced May 19, 2026
- EUDAMED e4ded88f-3bbf-4ff8-8b76-496b78d59fa6 61 fields · synced May 19, 2026
- FDA UDI bff687f3-9ede-4f59-b9b1-162c070c8397 32 fields · synced May 30, 2026