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TK Excalibur sterile fle
EUDAMEDClass IIa (EU MDR)
Ref ZRE252505DModel TK Excalibur sterile fle 25mm E25 (1 unit)
Identity
- Trade Name
- TK Excalibur sterile fle EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- TK Excalibur sterile fle 25mm E25 (1 unit) EUDAMEDZRE252505D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718050576 EUDAMED
- Basic UDI-DI
- B-06975718050576 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
TK Excalibur sterile fle by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975718050576 | Class IIa | Active |
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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 (1)
- EUDAMED 97225460-37ac-4434-8b81-68a65dfb47e4 61 fields · synced Jul 9, 2026