Identity
- Device Name
- Tubing Set for Blood Purification EUDAMED
- Model / Reference
- PE-FSL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547319000247 EUDAMED
- Basic UDI-DI
- 4547319FGM001_TSBPTQ EUDAMED
- EMDN Code
- B0380 APHERESIS DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Tubing Set for Blood Purification by Forte Grow Medical Co., Ltd. — Class IIa — 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 | 4547319FGM001_TSBPTQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Forte Grow Medical Co., Ltd.
- EUDAMED SRN
- JP-MF-000013444
- Authorised Representative
- Asahi Kasei Medical Europe GmbH DE-AR-000012752
Sources (1)
- EUDAMED 33f3933e-094a-4b56-9639-3553832f1425 61 fields · synced Jun 19, 2026