Identity
- Trade Name
- Visual Obturator f. resectoscope sheath EUDAMED
- Device Name
- Obturator for Hysteroscope sheath EUDAMED
- Model / Reference
- 20862-037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260214652198 EUDAMED
- Basic UDI-DI
- 426021465OBTURATORSA5 EUDAMED
- Direct Marketing DI
- 04260214652198 EUDAMED
- EMDN Code
- Z12020780 GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Visual Obturator f. resectoscope sheath by Erbe Vision GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope obturator.
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- USA Elite — Gyrus Acmi, Inc. · Class II
- Trabecular Metal® — Zimmer, Inc. · Class I
- SHARK — Richard Wolf GmbH · Class II
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 | 426021465OBTURATORSA5 | Class I | Active |
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Manufacturer
- Manufacturer
- Erbe Vision GmbH
- EUDAMED SRN
- DE-MF-000010268
Sources (1)
- EUDAMED 00e1573d-8169-4f16-9af3-40fa182717d2 61 fields · synced Jul 21, 2026