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Excalibur PRO sterile files
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZRE25PRO25Model Excalibur PRO sterile files 25mm E25 (3 units)Ref ZRE31PRO45Model Excalibur PRO sterile files 31mm E45 (6 units)
Identity
- Trade Name
- Excalibur PRO sterile files EUDAMEDAVALON BIOMED FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Model / Reference
- Excalibur PRO sterile files 25mm E25 (3 units) EUDAMEDZRE25PRO25 EUDAMEDExcalibur PRO sterile files 31mm E45 (6 units) EUDAMEDZRE31PRO45 EUDAMEDExcalibur PRO sterile 31mm E45 (6 units) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718055403 EUDAMED06975718058527 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06975718055403 EUDAMEDB-06975718058527 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
Excalibur PRO 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-06975718055403 | 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 (3)
- EUDAMED e1b96e0f-d65f-47c2-b591-6d03e6fe94ad 61 fields · synced Aug 4, 2026
- EUDAMED 8a027f3d-469e-43ba-9265-e6a69179175b 61 fields · synced May 18, 2026
- FDA UDI 51297d1f-487f-4f3c-8478-069bc28800e7 33 fields · synced May 30, 2026