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ApicalShaper sterile files
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZAS3105003Model ApicalShaper sterile files 31mm Z50/03 (6 units)Ref ZAS2103503Model ApicalShaper sterile files 21mm Z35/03 (6 units)Ref ZAS2104003Model ApicalShaper sterile files 21mm Z40/03 (6 units)Ref ZAS3103503Model ApicalShaper sterile files 31mm Z35/03 (6 units)Ref ZAS3103003Model ApicalShaper sterile files 31mm Z30/03 (6 units)
Identity
- Trade Name
- ApicalShaper sterile files EUDAMEDAVALON BIOMED FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Model / Reference
- ApicalShaper sterile files 31mm Z50/03 (6 units) EUDAMEDZAS3105003 EUDAMEDApicalShaper sterile files 21mm Z35/03 (6 units) EUDAMEDZAS2103503 EUDAMEDApicalShaper sterile files 21mm Z40/03 (6 units) EUDAMEDZAS2104003 EUDAMEDApicalShaper sterile files 31mm Z35/03 (6 units) EUDAMEDZAS3103503 EUDAMEDApicalShaper sterile files 31mm Z30/03 (6 units) EUDAMEDZAS3103003 EUDAMEDApicalShaper sterile 31mm Z30/03 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718050699 EUDAMED06975718050613 EUDAMED06975718050644 EUDAMED06975718050637 EUDAMED06975718050606 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06975718050699 EUDAMEDB-06975718050613 EUDAMEDB-06975718050644 EUDAMEDB-06975718050637 EUDAMEDB-06975718050606 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
- Not 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
No
FDA UDI
Radiation Sterilization FDA UDI
ApicalShaper sterile 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-06975718050699 | 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 (6)
- EUDAMED 03a21061-5c47-46fb-9719-ef40471963d4 61 fields · synced Sep 18, 2026
- EUDAMED caba47eb-9f20-4cd7-bc0e-d3f886b6f304 61 fields · synced May 17, 2026
- EUDAMED 21852dbb-afab-47fc-84c9-742956cdf119 61 fields · synced May 17, 2026
- EUDAMED 83fcef5c-80b1-45e0-b589-2f00a2d8df68 61 fields · synced May 18, 2026
- EUDAMED f165815a-acba-4a9a-a2b2-b4dbd84d5098 61 fields · synced May 19, 2026
- FDA UDI 1436b0bf-09da-4a2c-932b-1698e5513f5c 33 fields · synced May 30, 2026