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Endoscope Light Guide Sleeve - Pentax
EUDAMEDClass I (EU MDR)
Ref 06-6009 Model 06-6009
Identity
- Trade Name
- Endoscope Light Guide Sleeve - Pentax EUDAMED
- Device Name
- Endoscope Light Guide Sleeve - Pentax EUDAMED
- Model / Reference
- 06-6009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00896984000354 EUDAMED
- Basic UDI-DI
- 087448500GuideSleeve83 EUDAMED
- EMDN Code
- Z12020780 GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Endoscope Light Guide Sleeve - Pentax by Cogentix Medical, 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 | 087448500GuideSleeve83 | Class I | Active |
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Manufacturer
- Manufacturer
- Cogentix Medical, Inc.
- EUDAMED SRN
- US-MF-000041661
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (1)
- EUDAMED 59c96e9e-7f1e-42d1-87c6-5734642c71d0 61 fields · synced Jun 18, 2026