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TK SlimShaper
EUDAMEDClass IIa (EU MDR)
Ref ZSS25ASSTDModel TK SlimShaper sterile files 25mm ZS1-ZS3 (3 units)
Identity
- Trade Name
- TK SlimShaper EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- TK SlimShaper sterile files 25mm ZS1-ZS3 (3 units) EUDAMEDZSS25ASSTD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718050415 EUDAMED
- Basic UDI-DI
- B-06975718050415 EUDAMED
- EMDN Code
- Q030311 ENT SURGERY RASPS AND FILES, 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 SlimShaper 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-06975718050415 | 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 56a7030b-f887-4612-8747-006f7c4e5d77 61 fields · synced Jun 18, 2026