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Endo Stops
EUDAMEDFDA UDIClass I (EU MDR)
Ref 701-291Model ENDO STOPS DIRECTIONAL TYPE
Identity
- Trade Name
- ENDO STOPS EUDAMEDENDO STOPS_DIRECTIONAL TYPE FDA UDI
- Generic Name
- Endodontic instrument chairside holder set FDA UDI
- Device Name
- ENDO STOPS EUDAMEDENDO STOPS is 120 assorted colored stops packed in a plastic box FDA UDI
- Model / Reference
- ENDO STOPS DIRECTIONAL TYPE EUDAMED701-291 EUDAMEDASST FDA UDI
- Description
- ENDO STOPS is 120 assorted colored stops packed in a plastic box FDA UDI
Identifiers
- Catalog Number
- 701-291 FDA UDI
- Primary DI / UDI-DI
- 08806383521123 EUDAMEDFDA UDI
- Basic UDI-DI
- 88063835ESG8 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic instrument chairside holder set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Endo Stops by Diadent Group International — 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 | 88063835ESG8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diadent Group International
- EUDAMED SRN
- KR-MF-000023806
- Authorised Representative
- Diadent Europe B.V. NL-AR-000012597
Sources (2)
- EUDAMED fcee4138-2bbb-4304-8cbb-fb77b0d525b0 61 fields · synced Jul 8, 2026
- FDA UDI 027809bd-45fe-4484-b1f1-d870e3539317 34 fields · synced May 29, 2026