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sterile vaginal speculums for single use
EUDAMEDClass I (EU MDR)
Ref KVM002Model Middle Screw TypeRef KVM003Ref KJ-VS03AFModel French TypeRef KJ-VS03AERef KJ-VS03ADRef KVX001Model Spanish TypeRef KVM001Ref KJ-VS03ABRef KVX002Ref KJ-VS07AModel French type with middle screwRef KJ-VS03ACRef KJ-VS07FRef KJ-VS07BRef KJ-VS07ERef KVM004Ref KJ-VS03AG
Identity
- Device Name
- sterile vaginal speculums for single use EUDAMED
- Model / Reference
- Middle Screw Type EUDAMEDKVM002 EUDAMEDKVM003 EUDAMEDFrench Type EUDAMEDKJ-VS03AF EUDAMEDKJ-VS03AE EUDAMEDKJ-VS03AD EUDAMEDSpanish Type EUDAMEDKVX001 EUDAMEDKVM001 EUDAMEDKJ-VS03AB EUDAMEDKVX002 EUDAMEDFrench type with middle screw EUDAMEDKJ-VS07A EUDAMEDKJ-VS03AC EUDAMEDKJ-VS07F EUDAMEDKJ-VS07B EUDAMEDKJ-VS07E EUDAMEDKVM004 EUDAMEDKJ-VS03AG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950921000600 EUDAMED06950921000594 EUDAMED06950921000778 EUDAMED06950921000761 EUDAMED06950921000556 EUDAMED06950921000068 EUDAMED06950921000617 EUDAMED06950921000532 EUDAMED06950921000044 EUDAMED06950921000785 EUDAMED06950921000549 EUDAMED06950921000792 EUDAMED06950921000341 EUDAMED06950921000105 EUDAMED06950921000587 EUDAMED06950921000525 EUDAMED
- Basic UDI-DI
- 69509210ZLX67 EUDAMED69509210FKS2N EUDAMED69509210XKS5G EUDAMED69509210FZL3M EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDFrance EUDAMEDSpain 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 speculums for single use by Taizhou Kangjian Medical Equipments 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 | 69509210ZLX67 | Class I | Active |
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Manufacturer
- Manufacturer
- Taizhou Kangjian Medical Equipments Co., Ltd.
- EUDAMED SRN
- CN-MF-000011397
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (16)
- EUDAMED 60cbddeb-4912-4f22-8265-29133655dbdf 61 fields · synced Oct 6, 2026
- EUDAMED 7a947616-e0ac-43d4-ab74-baaceed6c974 61 fields · synced May 16, 2026
- EUDAMED b9f94f28-c8e4-4517-8571-ac3f569c804c 61 fields · synced May 16, 2026
- EUDAMED 9ab25a2e-d61d-48cc-8324-1750fb488fb8 61 fields · synced May 17, 2026
- EUDAMED 8985356a-c5ed-475b-9afb-87203013e833 61 fields · synced May 17, 2026
- EUDAMED f8770c0f-874a-42fe-a539-240b551f6a7f 61 fields · synced May 17, 2026
- EUDAMED 62257312-f4d2-4f6c-809f-e662ebf0cf66 61 fields · synced May 17, 2026
- EUDAMED 4ed9e144-67e9-4e07-8102-a4743ce141a8 61 fields · synced May 17, 2026
- EUDAMED 89350c11-36ee-476e-8dea-3eb30d410ff3 61 fields · synced May 18, 2026
- EUDAMED 1b30f356-7e4e-46ca-9c8f-ebd83573cb30 61 fields · synced May 18, 2026
- EUDAMED 1d595db6-27c9-4728-aabc-ab26233a1775 61 fields · synced May 18, 2026
- EUDAMED 2f7f5018-8590-4c63-9534-f2989d897687 61 fields · synced May 18, 2026
- EUDAMED 5004e34f-cb54-462b-82e3-c336a2e6fbd9 61 fields · synced May 18, 2026
- EUDAMED 8267c815-120a-4814-97f6-f4806a17c525 61 fields · synced May 19, 2026
- EUDAMED d54f78a3-1bf3-4db3-9b4c-7f0a89e46151 61 fields · synced May 19, 2026
- EUDAMED a54429dc-86bb-4393-aff0-7d198b58bdb5 61 fields · synced May 19, 2026