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Matrix Strips
EUDAMEDFDA UDIClass I (EU MDR)
Ref KSTRIP500Model Matrix StripsRef KSTRIP1000
Identity
- Trade Name
- Matrix Strips EUDAMEDFDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Matrix strips, 4 in x 0.375 in / 10 cm x 0.95 cm FDA UDI
- Model / Reference
- Matrix Strips EUDAMEDKSTRIP500 EUDAMEDFDA UDIKSTRIP1000 EUDAMEDFDA UDI
- Description
- Matrix strips, 4 in x 0.375 in / 10 cm x 0.95 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224003501 EUDAMEDFDA UDI10732224003518 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224MatrixbandJ7 EUDAMED
- Unit of Use DI
- 00732224003504 EUDAMED00732224003511 EUDAMED
- FDA Product Code
- EKF FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Matrix Strips by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0732224MatrixbandJ7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (6)
- EUDAMED 226f0be1-40a4-46e6-b541-5fbdcd5fd3c6 61 fields · synced Oct 5, 2026
- EUDAMED c49ffb2d-1082-4273-8e63-1fd04ad97a51 61 fields · synced May 18, 2026
- FDA UDI eda23067-5031-4849-a29f-451196fab749 34 fields · synced May 29, 2026
- FDA UDI ad49327d-bcff-4ae0-a180-a2f43cbab353 34 fields · synced May 30, 2026
- EUDAMED 7cd29c50-2aa8-4cc8-b20d-96ec0140a746 61 fields · synced Jul 13, 2026
- EUDAMED 375858c9-95d2-42f3-8282-477fa0220081 61 fields · synced Oct 5, 2026