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Pro-Flexi Files
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref D-P.01.03-021-VT-0A0-GD-000-00-00Model Pro-Flexi Files Gold 21mm 01/09,20/04,25/04,30/04,35/04,25/06 6pcs/pack
Identity
- Trade Name
- Pro-Flexi Files EUDAMEDDenco FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
- Device Name
- Pro-Flexi Files EUDAMED
- Model / Reference
- Pro-Flexi Files Gold 21mm 01/09,20/04,25/04,30/04,35/04,25/06 6pcs/pack EUDAMEDD-P.01.03-021-VT-0A0-GD-000-00-00 EUDAMED21mm Pro-Flexi Files(Heat Activation) Assorted FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718055304 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06975718055304 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Pro-Flexi Files by Shenzhen Denco Medical 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-06975718055304 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 7b16192c-46e5-4755-8ae2-62868463b36e 61 fields · synced Jun 18, 2026
- FDA UDI 7df2a4be-76c6-4236-bf15-9f05629a9b96 33 fields · synced May 30, 2026