Identity
- Trade Name
- Dental Instrument EUDAMEDDental Implants Accesseories-Reusable FDA UDI
- Generic Name
- Dental implant abutment analog, laboratory FDA UDI
- Device Name
- SFIT Absolute Digital Analog EUDAMED
- Model / Reference
- 2SSFLA4535 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016109986 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800016109986 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant abutment analog, laboratory 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
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
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-08800016109986 | 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 (2)
- EUDAMED ba406e88-688e-4a02-a4ba-d1bd332f9433 61 fields · synced May 31, 2026
- FDA UDI d55e6697-dffd-4a0e-925b-9a1ea418efce 32 fields · synced May 29, 2026