Identity
- Device Name
- Foley Balloon Catheters EUDAMED
- Model / Reference
- 1002F-12B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809690071084 EUDAMED
- Basic UDI-DI
- B-08809690071084 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Foley Balloon Catheters by Yushin Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809690071084 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Yushin Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000010526
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 5b964963-84a0-4113-99b9-d13b548076f0 61 fields · synced Jun 20, 2026