Identity
- Trade Name
- EXIMIA7 FDA UDI
- Generic Name
- Endodontic paper point FDA UDI
- Device Name
- Absorbent Paper Point EUDAMEDEXEMIA 7 PAPER POINTS 20/.06 - 100 PACK FDA UDI
- Model / Reference
- 02/15 EUDAMEDN/A EUDAMED020/06-H FDA UDI
- Description
- EXEMIA 7 PAPER POINTS 20/.06 - 100 PACK FDA UDI
Identifiers
- Catalog Number
- PPX72006 FDA UDI
- Primary DI / UDI-DI
- 06976245260278 EUDAMEDFDA UDI
- Basic UDI-DI
- 697060203APP0016K EUDAMED
- FDA Product Code
- EKN FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Endodontic paper point FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3830 FDA UDI
- Market of Registration
- Türkiye 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Absorbent Paper Point by Chengdu Sani Medical Equipment Co., Ltd — 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 | 697060203APP0016K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Chengdu Sani Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000011715
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED ed265e45-84cd-4067-9e3c-28f5418033ab 61 fields · synced Oct 6, 2026
- FDA UDI 27ffd170-88dd-466f-bdbe-0dfd91882f3e 35 fields · synced May 22, 2026