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Obturator for Cysto/Urethroscope
EUDAMEDClass I (EU MDR)
Ref 20864-010Ref 20864-012
Identity
- Trade Name
- Obturator for Cysto/Urethroscope EUDAMED
- Device Name
- Obturator for Hysteroscope sheath EUDAMED
- Model / Reference
- 20864-010 EUDAMED20864-012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260214652877 EUDAMED04260214652891 EUDAMED
- Basic UDI-DI
- 426021465OBTURATORSA5 EUDAMED
- Direct Marketing DI
- 04260214652877 EUDAMED04260214652891 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
Obturator for Cysto/Urethroscope by Erbe Vision GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope obturator.
- Arthroscopy bridge — SOPRO-COMEG GmbH · Class II
- Biportal Laminoscope, ocular — Joimax GmbH · Class IIa
- TAUT — TELEFLEX INCORPORATED · Class II
- Hysteroscopy obturator — SOPRO-COMEG GmbH · Class II
- Spinal surgery spongiosa pushers — Richard Wolf GmbH · Class I
- 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 (2)
- EUDAMED 15fc1e11-a604-4e8f-bcea-7f32989ec028 61 fields · synced Jul 16, 2026
- EUDAMED 249863ce-24ed-4420-9b69-f8789b50344e 61 fields · synced May 19, 2026