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Gynecological Set for Single Use
EUDAMEDClass I (EU MDR)
Ref F015-5*A43-101-0-MM103001Model FJB-015
Identity
- Trade Name
- Gynecological Set for Single Use EUDAMED
- Model / Reference
- FJB-015 EUDAMEDF015-5*A43-101-0-MM103001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970097893035 EUDAMED
- Basic UDI-DI
- 697009789FJB015HP EUDAMED
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Gynecological Set for Single Use by Changzhou Shunfeng Plastic 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 | 697009789FJB015HP | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Shunfeng Plastic Co., Ltd.
- EUDAMED SRN
- CN-MF-000014926
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4fc1bb63-952b-42ad-b495-889e73514525 61 fields · synced Jun 19, 2026