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S.S Barbed Broaches
EUDAMEDClass IIa (EU MDR)
Ref CODE383XFModel E38 S.S Barbed Broaches 10s 21mm (3)XFRef CODE386CModel E38 S.S Barbed Broaches 10s 21mm (6)CRef CODE385MModel E38 S.S Barbed Broaches 10s 21mm (5)MRef CODE380XXXXFModel E38 S.S Barbed Broaches 10s 21mm (0)XXXXFRef CODE382XXFModel E38 S.S Barbed Broaches 10s 21mm (2)XXF
Identity
- Trade Name
- S.S Barbed Broaches EUDAMED
- Device Name
- Dental Root Canal Instruments Barbed Broaches EUDAMED
- Model / Reference
- E38 S.S Barbed Broaches 10s 21mm (3)XF EUDAMEDCODE383XF EUDAMEDE38 S.S Barbed Broaches 10s 21mm (6)C EUDAMEDCODE386C EUDAMEDE38 S.S Barbed Broaches 10s 21mm (5)M EUDAMEDCODE385M EUDAMEDE38 S.S Barbed Broaches 10s 21mm (0)XXXXF EUDAMEDCODE380XXXXF EUDAMEDE38 S.S Barbed Broaches 10s 21mm (2)XXF EUDAMEDCODE382XXF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512506103 EUDAMED06942512506134 EUDAMED06942512506127 EUDAMED06942512506073 EUDAMED06942512506097 EUDAMED
- Basic UDI-DI
- B-06942512506103 EUDAMEDB-06942512506134 EUDAMEDB-06942512506127 EUDAMEDB-06942512506073 EUDAMEDB-06942512506097 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
S.S Barbed Broaches 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-06942512506103 | 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 (5)
- EUDAMED 44935716-8e50-4969-a262-fc19719b2a00 61 fields · synced Aug 2, 2026
- EUDAMED e90c416a-af0c-422f-8a27-814820392cba 61 fields · synced May 16, 2026
- EUDAMED b7496134-1fc3-4ea7-909c-c673933b5d07 61 fields · synced May 16, 2026
- EUDAMED 61467429-e9ab-4feb-b1ca-a598a2762c64 61 fields · synced May 17, 2026
- EUDAMED 3f8bca05-b6c2-4e93-bad4-f3ee0d89d5b2 61 fields · synced May 17, 2026