← Back to catalogue
Limas SlimShaper
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZSS3100001Model Limas SlimShaper estériles 31mm ZS1 (6 uds.)Ref ZSS3100003Model Limas SlimShaper estériles 31mm ZS3 (6 uds.)Ref ZSS25ASST6Model Limas SlimShaper estériles 25mm ZS1-ZS3 (6 uds)Ref ZSS2100003Model Limas SlimShaper estériles 21mm ZS3 (6 uds.)
Identity
- Trade Name
- Limas SlimShaper EUDAMEDAVALON BIOMED FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Limas SlimShaper estériles 31mm ZS1 (6 uds.) EUDAMEDZSS3100001 EUDAMEDLimas SlimShaper estériles 31mm ZS3 (6 uds.) EUDAMEDZSS3100003 EUDAMEDLimas SlimShaper estériles 25mm ZS1-ZS3 (6 uds) EUDAMEDZSS25ASST6 EUDAMEDLimas SlimShaper estériles 21mm ZS3 (6 uds.) EUDAMEDZSS2100003 EUDAMEDSlimShaper sterile 21mm ZS3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718050385 EUDAMED06975718050408 EUDAMED06975718050330 EUDAMED06975718050323 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06975718050385 EUDAMEDB-06975718050408 EUDAMEDB-06975718050330 EUDAMEDB-06975718050323 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMEDQ030311 ENT SURGERY RASPS AND FILES, 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
Limas SlimShaper 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-06975718050385 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (5)
- EUDAMED 9266c5bb-2b23-40d2-92ad-80aa7cf32ea3 61 fields · synced Aug 2, 2026
- EUDAMED ae5196fa-e042-437b-9948-10aa465c72f2 61 fields · synced May 18, 2026
- EUDAMED cf3ddec5-ba2c-440d-b1a8-f45576fbbc02 61 fields · synced May 18, 2026
- EUDAMED d989f62e-0dfa-4122-8871-da0a1179f8c4 61 fields · synced May 19, 2026
- FDA UDI c1d9b0a5-dd8b-43dc-9fd2-9d4e9d05fc60 33 fields · synced May 30, 2026