Brushes
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Batrik Arc Wire Brushes Single Use FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- Brushes EUDAMEDBrush/White/BD 2mm/BL 15mm/OL 60cm - Flexible - SINGLE USE FDA UDI
- Model / Reference
- 30-23050K EUDAMED41-61502-S EUDAMEDFDA UDI35-23025F EUDAMED41-77504-S EUDAMED
- Description
- Brush/White/BD 2mm/BL 15mm/OL 60cm - Flexible - SINGLE USE FDA UDI
Identifiers
- Catalog Number
- 41-61502-S FDA UDI
- Primary DI / UDI-DI
- 00690521006850 EUDAMED00690521008588 EUDAMEDFDA UDI00690521012578 EUDAMED00690521008861 EUDAMED
- Basic UDI-DI
- 6905210BRUSH10007A EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- V070101 ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE EUDAMEDV070105 INSTRUMENTS CLEANING BRUSHES EUDAMED
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical instrument/endoscope cleaning utensil, single-use
Brushes by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/endoscope cleaning utensil, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6905210BRUSH10007A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (5)
- EUDAMED 8cf2f4a9-6881-401d-81da-084289b9eb74 61 fields · synced Sep 30, 2026
- EUDAMED 4ff9c393-eaec-4ef2-bf44-f27dc3f38c38 61 fields · synced May 18, 2026
- EUDAMED 8fc2a151-0611-4d4f-8865-0273bad840b9 61 fields · synced May 18, 2026
- EUDAMED 738cf02c-38a3-4ea4-8d86-d00ca9c89d69 61 fields · synced May 19, 2026
- FDA UDI 500f7829-2a1c-4188-aced-2363cb053daa 36 fields · synced May 25, 2026