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Elements Connect
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 815-1801Model Elements Connect
Identity
- Trade Name
- Elements Connect EUDAMEDFDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- Cordless Endodontic Motor EUDAMEDElements Connect Cordless Motor Kit - EU FDA UDI
- Model / Reference
- Elements Connect EUDAMED815-1801 EUDAMEDFDA UDI
- Description
- Elements Connect Cordless Motor Kit - EU FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809455601402 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809455601402 EUDAMED
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Elements Connect by Meta Systems Co., Ltd. — Class IIa — 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-08809455601402 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Meta Systems Co., Ltd.
- EUDAMED SRN
- KR-MF-000022945
- Authorised Representative
- Meta Biomed Europe GmbH DE-AR-000004953
Sources (2)
- EUDAMED 59050aeb-a03e-4789-ab85-66296ce1dccb 61 fields · synced Jul 21, 2026
- FDA UDI e14e3408-51e9-4645-8bac-a12ddae81e9d 33 fields · synced May 30, 2026