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H File
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZHEDST2510Model H File 25mm 10 (6 units)Ref ZHEDST2145Model H File 21mm 45 (6 units)Ref ZHD31ASST1Model H File 31mm 15-40 (6 units)Ref ZHEDST2125Model H File 21mm 25 (6 units)Ref ZHEDST3130Model H File 31mm 30 (6 units)Ref ZHD31ASST2Model H File 31mm 45-80 (6 units)Ref ZHEDST2140Model H File 21mm 40 (6 units)Ref ZHEDST3140Model H File 31mm 40 (6 units)Ref ZHEDST3125Model H File 31mm 25 (6 units)
Identity
- Trade Name
- H File EUDAMEDZARC FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Model / Reference
- H File 25mm 10 (6 units) EUDAMEDZHEDST2510 EUDAMEDH File 21mm 45 (6 units) EUDAMEDZHEDST2145 EUDAMEDH File 31mm 15-40 (6 units) EUDAMEDZHD31ASST1 EUDAMEDH File 21mm 25 (6 units) EUDAMEDZHEDST2125 EUDAMEDH File 31mm 30 (6 units) EUDAMEDZHEDST3130 EUDAMEDH File 31mm 45-80 (6 units) EUDAMEDZHD31ASST2 EUDAMEDH File 21mm 40 (6 units) EUDAMEDZHEDST2140 EUDAMEDH File 31mm 40 (6 units) EUDAMEDZHEDST3140 EUDAMEDH File 31mm 25 (6 units) EUDAMEDZHEDST3125 EUDAMEDHedstrom sterile files 31mm 25 (6 units) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718051672 EUDAMED06975718051627 EUDAMED06975718051870 EUDAMED06975718051580 EUDAMED06975718051832 EUDAMED06975718051887 EUDAMED06975718051610 EUDAMED06975718051856 EUDAMED06975718051825 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06975718051672 EUDAMEDB-06975718051627 EUDAMEDB-06975718051870 EUDAMEDB-06975718051580 EUDAMEDB-06975718051832 EUDAMEDB-06975718051887 EUDAMEDB-06975718051610 EUDAMEDB-06975718051856 EUDAMEDB-06975718051825 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Manual 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
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
H File 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-06975718051672 | 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 (10)
- EUDAMED 81fb899b-4c25-4f23-96fb-49453c032415 61 fields · synced Sep 17, 2026
- EUDAMED d448b5b6-9fe0-4801-b714-d3fe8c526a98 61 fields · synced May 17, 2026
- EUDAMED 19eebd38-252f-44cf-93d5-e8e982e5242a 61 fields · synced May 17, 2026
- EUDAMED e524b27b-f232-44e6-b598-0208f8484b1a 61 fields · synced May 17, 2026
- EUDAMED 27bba08c-e812-4ff2-819b-d6c31c22ff07 61 fields · synced May 18, 2026
- EUDAMED e65cbab0-45f8-43a3-8390-c084e7c29dc2 61 fields · synced May 18, 2026
- EUDAMED 4099c467-c582-4f7c-b5ed-89ac8ef34f4e 61 fields · synced May 18, 2026
- EUDAMED 5b742d25-0dbf-4e6a-9fa8-f35b0784baeb 61 fields · synced May 19, 2026
- EUDAMED 1b2eaf9f-f4e2-45b0-89d5-844c055bf165 61 fields · synced May 19, 2026
- FDA UDI 9ef43e64-ea15-4a6d-afd8-f953d69442e5 33 fields · synced May 30, 2026