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Gauze balls with X-ray thread, sterile
EUDAMEDClass IIa (EU MDR)
Ref TF151510-SSXRModel 570001
Identity
- Trade Name
- Gauze balls with X-ray thread, sterile EUDAMED
- Device Name
- Gauze ball with X-Ray EUDAMED
- Model / Reference
- 570001 EUDAMEDTF151510-SSXR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948788178648 EUDAMED
- Basic UDI-DI
- 694878812003PZ EUDAMED
- EMDN Code
- M0201050201 COTTON GAUZE PADS, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Gauze balls with X-ray thread, sterile by Hubei Qianjiang Kingphar Medical Material Co., Ltd — Class IIa — MDR — listed in EUDAMED
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 | 694878812003PZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hubei Qianjiang Kingphar Medical Material Co., Ltd
- EUDAMED SRN
- CN-MF-000009051
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 88d36732-d381-491a-9cbc-7f574e33f007 61 fields · synced Oct 6, 2026