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Vaginal Secretions Analysis Strip
EUDAMEDClass IVD General (EU MDR)
Ref 3018417Model 100 strips/bottle (GMD-7)Ref 3018413Model 100 strips/bottle (GMD-6B)Ref 3018409Model 100 strips/bottle (GMD-9N)
Identity
- Trade Name
- Vaginal Secretions Analysis Strip EUDAMED
- Device Name
- Vaginal Secretions Analysis Strip EUDAMED
- Model / Reference
- 100 strips/bottle (GMD-7) EUDAMED3018417 EUDAMED100 strips/bottle (GMD-6B) EUDAMED3018413 EUDAMED100 strips/bottle (GMD-9N) EUDAMED3018409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794591210 EUDAMED06925794591197 EUDAMED06925794591234 EUDAMED
- Basic UDI-DI
- B-06925794591210 EUDAMEDB-06925794591197 EUDAMEDB-06925794591234 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Vaginal Secretions Analysis Strip by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06925794591210 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 244e06be-ac1d-4871-86ec-d6c6d04aa708 61 fields · synced Jul 20, 2026
- EUDAMED b2e2a93a-9b92-4c62-bf09-3bc7eb2e3808 61 fields · synced May 17, 2026
- EUDAMED ceba757d-7615-4840-9fd6-f60fb9d983e7 61 fields · synced May 18, 2026