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Gel and probe cover kit
EUDAMEDClass I (EU MDR)
Ref 11134Model DPK-6x120, DPK-8x50, DPK-10x60, DPK-14x30
Identity
- Trade Name
- Gel and probe cover kit EUDAMED
- Device Name
- Disposable Needle Guides Kit EUDAMED
- Model / Reference
- DPK-6x120, DPK-8x50, DPK-10x60, DPK-14x30 EUDAMED11134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975122551348 EUDAMED
- Basic UDI-DI
- 69715547209XA EUDAMED
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Gel and probe cover kit by JingFang Precision Medical Device(Shenzhen) 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 | 69715547209XA | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000014096
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f69b806b-2c8f-4d6f-8d0e-3b31135094b4 61 fields · synced Jun 18, 2026