← Back to catalogue
EdgeEndo Endoring Foam: Combo
EUDAMEDFDA UDIClass I (EU MDR)
Ref ERFEE-SModel ERK-EX-S
by Jordco, Inc.
Identity
- Trade Name
- EdgeEndo Endoring Foam: Combo EUDAMEDEndoring FDA UDI
- Generic Name
- Endodontic instrument-holding insert, single-use FDA UDI
- Device Name
- ENDORING EUDAMEDEndoring e-Foam Insert EdgeEndo; combo pack FDA UDI
- Model / Reference
- ERK-EX-S EUDAMEDERFEE-S EUDAMEDFDA UDI
- Description
- Endoring e-Foam Insert EdgeEndo; combo pack FDA UDI
Identifiers
- Catalog Number
- ERFEE-S FDA UDI
- Primary DI / UDI-DI
- 00818365021345 EUDAMED00859611006471 FDA 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-holding insert, single-use 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
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
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
Moist Heat or Steam Sterilization FDA UDI
EdgeEndo Endoring Foam: Combo 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jordco, Inc.
- EUDAMED SRN
- US-MF-000021671
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 12826add-955e-4fd2-a97c-a5200e74c337 61 fields · synced Jun 19, 2026
- FDA UDI 9ca9f790-b7e5-43b9-bf49-27c2c1796cff 35 fields · synced May 30, 2026