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Kerr Endoring Gelwells
EUDAMEDClass I (EU MDR)
Ref 825-0051Model ERK-EX-S
by Jordco, Inc.
Identity
- Trade Name
- Kerr Endoring Gelwells EUDAMED
- Device Name
- ENDORING EUDAMED
- Model / Reference
- ERK-EX-S EUDAMED825-0051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195062019067 EUDAMED
- Basic UDI-DI
- 00859611ENDORINGUU EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Kerr Endoring Gelwells by Jordco, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00859611ENDORINGUU | Class I | Active |
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Manufacturer
- Manufacturer
- Jordco, Inc.
- EUDAMED SRN
- US-MF-000021671
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED af947e3c-c14e-437e-9cb6-f8d76a9f361f 61 fields · synced Jun 19, 2026