Identity
- Trade Name
- EXIMIA7 FDA UDI
- Generic Name
- Natural gutta-percha FDA UDI
- Device Name
- Gutta Percha Point EUDAMEDEXEMIA 7 GUTTA PERCHA 35/.04 - 60 PACK FDA UDI
- Model / Reference
- N/A EUDAMED035/04-H FDA UDI
- Description
- EXEMIA 7 GUTTA PERCHA 35/.04 - 60 PACK FDA UDI
Identifiers
- Catalog Number
- GPX73504 FDA UDI
- Primary DI / UDI-DI
- 06974242199102 EUDAMEDFDA UDI
- Basic UDI-DI
- 697060203GPP0018Z EUDAMED
- FDA Product Code
- EKM FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Natural gutta-percha FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3850 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
Yes
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
Gutta Percha Point by Chengdu Sani Medical Equipment Co., Ltd — Class IIa — 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 | 697060203GPP0018Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 e41efb6d-7117-48a6-9930-d644fca86926 61 fields · synced Oct 6, 2026
- FDA UDI ffa58b4f-739a-4113-b873-ea0d107bfb6c 35 fields · synced May 30, 2026