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Endoring Gelwells
EUDAMEDFDA UDIClass I (EU MDR)
Ref ERG-SModel ERK-EX-S
by Jordco, Inc.
Identity
- Trade Name
- Endoring Gelwells EUDAMEDEndoring FDA UDI
- Generic Name
- Endodontic instrument chairside holder set FDA UDI
- Device Name
- ENDORING EUDAMEDEndoring Gelwell cups FDA UDI
- Model / Reference
- ERK-EX-S EUDAMEDERG-S EUDAMEDFDA UDI
- Description
- Endoring Gelwell cups FDA UDI
Identifiers
- Catalog Number
- ERG-S FDA UDI
- Primary DI / UDI-DI
- 00859611006242 EUDAMEDFDA UDI
- Basic UDI-DI
- 00859611ENDORINGUU EUDAMED
- FDA Product Code
- EIL FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Endodontic instrument chairside holder set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
Yes
FDA UDI
High-level Disinfectant FDA UDI
Endoring Gelwells by Jordco, 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 | 00859611ENDORINGUU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jordco, Inc.
- EUDAMED SRN
- US-MF-000021671
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED d5993a5e-0b82-412b-9b0c-cf2491b3b815 61 fields · synced Jul 27, 2026
- FDA UDI fd59b7be-2636-4802-86f1-6e2024193689 34 fields · synced May 30, 2026