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Disposable Vaginal Speculum
EUDAMEDClass I (EU MDR)
Ref 0511-1Ref 0507-1Ref 0507-4Ref 0502-4Ref 0506-1Ref 0507-3Ref 0502-3Ref 0507-2
Identity
- Trade Name
- Disposable Vaginal Speculum EUDAMED
- Device Name
- Disposable Vaginal Speculum EUDAMED
- Model / Reference
- 0511-1 EUDAMED0507-1 EUDAMED0507-4 EUDAMED0502-4 EUDAMED0506-1 EUDAMED0507-3 EUDAMED0502-3 EUDAMED0507-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949717003246 EUDAMED06949717003208 EUDAMED06949717003239 EUDAMED06949717003154 EUDAMED06949717003161 EUDAMED06949717003222 EUDAMED06949717003147 EUDAMED06949717003215 EUDAMED
- Basic UDI-DI
- 69497170DVD1023R9 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
Disposable Vaginal Speculum by Ningbo HLS Medical Products 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 | 69497170DVD1023R9 | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo HLS Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000026849
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (8)
- EUDAMED 4ce0b94a-450e-435c-888d-3621d26d84eb 61 fields · synced Oct 6, 2026
- EUDAMED e4cd92e0-58f6-4b28-938f-0fd34b8e3f82 61 fields · synced May 17, 2026
- EUDAMED bc927158-a02f-46c3-b1a5-ed8d5cd2e203 61 fields · synced May 17, 2026
- EUDAMED 6cc6780f-429c-4386-b3e8-8f95ac549908 61 fields · synced May 18, 2026
- EUDAMED 7a72aec0-3334-4384-899b-274013841479 61 fields · synced May 18, 2026
- EUDAMED 70d8d0e5-74da-42bd-8feb-af2f8ca6e743 61 fields · synced May 18, 2026
- EUDAMED 022757c6-883d-432d-960a-80891bb50a39 61 fields · synced May 19, 2026
- EUDAMED 1b9f7e8c-38a8-4b16-86f2-977f0ac3c945 61 fields · synced May 19, 2026