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Limas BlueShaper
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZBS25Z0001Model Limas BlueShaper estériles 25mm Z1 (6 uds.)
Identity
- Trade Name
- Limas BlueShaper EUDAMEDAVALON BIOMED FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Limas BlueShaper estériles 25mm Z1 (6 uds.) EUDAMEDZBS25Z0001 EUDAMEDBlueShaper sterile 25mm Z1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718050149 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06975718050149 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q030311 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 BlueShaper 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-06975718050149 | 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 (2)
- EUDAMED 290cc9b9-6590-4a5f-89db-da0b3b510423 61 fields · synced Jun 17, 2026
- FDA UDI 79509839-7a25-4b0e-9513-d5bcdcb8a4af 33 fields · synced May 30, 2026