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Pro-Path
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PP.25.16Model PP.25.16 Pro-Path Feile 25mm #016Ref PP.31.16Model PP.31.16 Pro-Path Feile 31mm #016Ref D-P.01.12-021-VT-016-GD-000-00-00Model Pro-Path 21mm #016 6pcs/packRef D-P.01.12-025-VT-016-GD-000-00-00Model Pro-Path 25mm #016 6pcs/packRef D-P.01.12-021-VT-016-RB-000-00-00Model Chameleon Series -Pro Path 21mm #016 6pcs/blisterRef D-P.01.12-031-VT-016-GD-000-00-00Model Pro-Path 31mm #016 6pcs/pack
Identity
- Trade Name
- Pro-Path EUDAMEDDenco FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
- Device Name
- Pro-Path EUDAMED
- Model / Reference
- PP.25.16 Pro-Path Feile 25mm #016 EUDAMEDPP.25.16 EUDAMEDPP.31.16 Pro-Path Feile 31mm #016 EUDAMEDPP.31.16 EUDAMEDPro-Path 21mm #016 6pcs/pack EUDAMEDD-P.01.12-021-VT-016-GD-000-00-00 EUDAMEDPro-Path 25mm #016 6pcs/pack EUDAMEDD-P.01.12-025-VT-016-GD-000-00-00 EUDAMEDChameleon Series -Pro Path 21mm #016 6pcs/blister EUDAMEDD-P.01.12-021-VT-016-RB-000-00-00 EUDAMEDPro-Path 31mm #016 6pcs/pack EUDAMEDD-P.01.12-031-VT-016-GD-000-00-00 EUDAMED31mm PRO-PATH #016 FDA UDI25mm PRO-PATH #016 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06942512512531 EUDAMED06942512512548 EUDAMED06975718056172 EUDAMEDFDA UDI06970514919775 EUDAMEDFDA UDI06975718057377 EUDAMED06975718057384 EUDAMED
- Basic UDI-DI
- B-06942512512531 EUDAMEDB-06942512512548 EUDAMEDB-06975718057377 EUDAMEDB-06970514919775 EUDAMEDB-06975718057384 EUDAMEDB-06975718056172 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
- Germany EUDAMEDTürkiye EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMEDFDA 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-Path 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-06942512512531 | 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 (8)
- EUDAMED fe134a22-09cc-4594-821e-8613c77e75b9 61 fields · synced Jul 25, 2026
- EUDAMED d08be95d-0bc4-49a6-979d-91d7b2d0dfcf 61 fields · synced May 19, 2026
- FDA UDI 2dbcaab1-b393-4849-95ee-61d4b3564505 33 fields · synced May 29, 2026
- FDA UDI ab8225f9-46a6-4bd1-9a6a-3c5ae5b24967 33 fields · synced May 30, 2026
- EUDAMED dee03e1a-3845-41af-848b-09df6044a79a 61 fields · synced Jun 18, 2026
- EUDAMED 815a69bf-dfae-4f71-989e-46bdf5c4d037 61 fields · synced Jun 20, 2026
- EUDAMED e81acd5f-e519-4777-903b-3a76c32613c0 61 fields · synced Jul 15, 2026
- EUDAMED e31f6841-6967-4d52-9211-882ce86da30a 61 fields · synced Jul 25, 2026