← Back to catalogue
Gynecological Set for Single Use
EUDAMEDClass I (EU MDR)
Ref F058-5AA43-121-2-MM113111Model FJB-058
Identity
- Trade Name
- Gynecological Set for Single Use EUDAMED
- Model / Reference
- FJB-058 EUDAMEDF058-5AA43-121-2-MM113111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970097893028 EUDAMED
- Basic UDI-DI
- 697009789FJB058J9 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 | 697009789FJB058J9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 6468b828-ace0-4df2-8ac1-57658b8fdbbd 61 fields · synced Aug 3, 2026