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Stainless Steel Electrolytic Abrasive Strips 4, 0mm – Double Face - C/ 12
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10304008
Identity
- Trade Name
- STAINLESS STEEL ELECTROLYTIC ABRASIVE STRIPS 4,0MM – DOUBLE FACE - C/ 12 EUDAMEDMicrodont FDA UDI
- Generic Name
- Dental abrasive strip, single-use FDA UDI
- Device Name
- DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMEDStainless Steel Abrasive Strip - 4,0mm - Double Face - Box w/12 pcs FDA UDI
- Model / Reference
- 10304008 EUDAMED10.304.008 FDA UDI
- Description
- Stainless Steel Abrasive Strip - 4,0mm - Double Face - Box w/12 pcs FDA UDI
Identifiers
- Catalog Number
- 10.304.008 FDA UDI
- Primary DI / UDI-DI
- 07908516834634 EUDAMEDFDA UDI
- Basic UDI-DI
- 79085168stripsB2 EUDAMED
- FDA Product Code
- EHM FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive strip, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Stainless Steel Electrolytic Abrasive Strips 4, 0mm – Double Face - C/ 12 by 3R Indústria E Comércio LTDA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 79085168stripsB2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3R Indústria E Comércio LTDA
- EUDAMED SRN
- BR-MF-000034808
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED ff9bebce-8c98-4460-bb8d-394052fe15fd 61 fields · synced Jun 18, 2026
- FDA UDI d044959e-3b8c-4fc7-af98-f65ce03252a3 34 fields · synced May 29, 2026