Identity
- Trade Name
- Sterile Vaginal Speculum EUDAMED
- Device Name
- Sterile Vaginal Speculum EUDAMED
- Model / Reference
- CJ9022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957933290227 EUDAMED
- Basic UDI-DI
- 69579332cj00264 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Vaginal Speculum by Changzhou Chuangjia Medical Appliance Co., Ltd. — 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 | 69579332cj00264 | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Chuangjia Medical Appliance Co., Ltd.
- EUDAMED SRN
- CN-MF-000026071
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 89d711bd-70d8-44e4-8716-c9a69f38602c 61 fields · synced Jun 19, 2026