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EUDAMEDFDA UDIClass I (EU MDR)
Ref 530030Ref 5300/6Ref 530050Ref 530040Ref 530070
Identity
- Trade Name
- stop card EUDAMEDFDA UDI
- Generic Name
- Endodontic stopper FDA UDI
- Device Name
- Endodontic accessories EUDAMEDgreen FDA UDI
- Model / Reference
- 530030 EUDAMED5300/6 EUDAMEDFDA UDI530050 EUDAMED530040 EUDAMED530070 EUDAMED
- Description
- green FDA UDI
Identifiers
- Primary DI / UDI-DI
- +E2995300300 EUDAMED+E2995300/60 EUDAMED+E2995300500 EUDAMED+E2995300400 EUDAMED+E2995300700 EUDAMEDE299530060 FDA UDI
- Basic UDI-DI
- ++E299ENDOACCESSORIESCT EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic stopper FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Liechtenstein 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
stop card by Polydentia SA — 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 | ++E299ENDOACCESSORIESCT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Polydentia SA
- EUDAMED SRN
- CH-MF-000008779
- Authorised Representative
- IDD International Dental Distributors AG LI-AR-000008367
Sources (6)
- EUDAMED 38f53376-02de-43fe-8e4c-c00185dd2eef 61 fields · synced Jul 31, 2026
- EUDAMED 11d42a38-1b58-49ce-82b0-5de01469ba51 61 fields · synced May 18, 2026
- EUDAMED 7cdec48d-479e-465f-85bd-f20fdc832272 61 fields · synced May 18, 2026
- EUDAMED 5f4ad820-e93d-4397-b0dd-112262bca9ed 61 fields · synced May 18, 2026
- EUDAMED 0ca07fe5-adb0-4926-84bb-163769c4d1c4 61 fields · synced May 19, 2026
- FDA UDI ad5e3d9a-b289-47b4-82e2-5b02ed5495b7 34 fields · synced May 30, 2026