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Endoscope Light Guide Sleeve - Wolf
EUDAMEDClass I (EU MDR)
Ref 06-6020 Model 06-6009
Identity
- Trade Name
- Endoscope Light Guide Sleeve - Wolf EUDAMED
- Device Name
- Endoscope Light Guide Sleeve - Pentax EUDAMED
- Model / Reference
- 06-6009 EUDAMED06-6020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00896984000361 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
Category: Rigid endoscope obturator
Endoscope Light Guide Sleeve - Wolf by Cogentix Medical, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 50bc598f-d9a9-489b-9673-ace1568269b0 61 fields · synced Jul 9, 2026