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Limas SlimShaper PRO estériles
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZSS210PRO3Model Limas SlimShaper PRO estériles 21mm ZS3 (6 uds.)Ref ZSS210PRO1Model Limas SlimShaper PRO estériles 21mm ZS1 (6 uds.)Ref ZSS31APRO3Model Limas SlimShaper PRO estériles 31mm ZS1-ZS3 (3 uds.)Ref ZSS31APRO6Model Limas SlimShaper PRO estériles 31mm ZS1-ZS3 (6 uds.)Ref ZSS21APRO3Model Limas SlimShaper PRO estériles 21mm ZS1-ZS3 (3 uds.)Ref ZSS21APRO6Model Limas SlimShaper PRO estériles 21mm ZS1-ZS3 (6 uds.)Ref ZSS310PRO1Model Limas SlimShaper PRO estériles 31mm ZS1 (6 uds.)Ref ZSS210PRO2Model Limas SlimShaper PRO estériles 21mm ZS2 (6 uds.)
Identity
- Trade Name
- Limas SlimShaper PRO estériles EUDAMEDZARC FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Limas SlimShaper PRO estériles 21mm ZS3 (6 uds.) EUDAMEDZSS210PRO3 EUDAMEDLimas SlimShaper PRO estériles 21mm ZS1 (6 uds.) EUDAMEDZSS210PRO1 EUDAMEDLimas SlimShaper PRO estériles 31mm ZS1-ZS3 (3 uds.) EUDAMEDZSS31APRO3 EUDAMEDLimas SlimShaper PRO estériles 31mm ZS1-ZS3 (6 uds.) EUDAMEDZSS31APRO6 EUDAMEDLimas SlimShaper PRO estériles 21mm ZS1-ZS3 (3 uds.) EUDAMEDZSS21APRO3 EUDAMEDLimas SlimShaper PRO estériles 21mm ZS1-ZS3 (6 uds.) EUDAMEDZSS21APRO6 EUDAMEDLimas SlimShaper PRO estériles 31mm ZS1 (6 uds.) EUDAMEDZSS310PRO1 EUDAMEDLimas SlimShaper PRO estériles 21mm ZS2 (6 uds.) EUDAMEDZSS210PRO2 EUDAMEDSlimShaper PRO sterile files 21mm ZS2 (6 units) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718055502 EUDAMED06975718055441 EUDAMED06975718055571 EUDAMED06975718055557 EUDAMED06975718055564 EUDAMED06975718055533 EUDAMED06975718055465 EUDAMED06975718055472 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06975718055502 EUDAMEDB-06975718055441 EUDAMEDB-06975718055571 EUDAMEDB-06975718055557 EUDAMEDB-06975718055564 EUDAMEDB-06975718055533 EUDAMEDB-06975718055465 EUDAMEDB-06975718055472 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
Limas SlimShaper PRO estériles 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-06975718055502 | 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 (9)
- EUDAMED 924ec2a1-307c-49a1-ae4a-1e70e9e634aa 61 fields · synced Sep 18, 2026
- EUDAMED 669ea37e-a9bf-44c3-8239-2af0f1ac4c33 61 fields · synced May 17, 2026
- EUDAMED a6073c03-0448-4d43-9767-c4931d54235e 61 fields · synced May 17, 2026
- EUDAMED 4fe17880-43e6-4490-aa26-7b94dbc73d1f 61 fields · synced May 17, 2026
- EUDAMED aeca43e0-260a-48fd-b457-2eac3fb5be73 61 fields · synced May 17, 2026
- EUDAMED a13e8327-d44c-4966-a21f-c93c3348aaeb 61 fields · synced May 18, 2026
- EUDAMED 6ececa39-2864-4ad3-b7a8-7d61d19a2717 61 fields · synced May 18, 2026
- EUDAMED 9c4136fb-ca42-446e-b018-43004864793f 61 fields · synced May 19, 2026
- FDA UDI 407ad880-84b0-4dd1-a96e-aa059f59b34c 33 fields · synced May 30, 2026