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Safety Subcutaneous Infusion Set 1 Needle, 27G, 12 mm, 40 cm Tube
EUDAMEDClass IIb (EU MDR)
Ref 418460
Identity
- Trade Name
- Safety Subcutaneous Infusion Set 1 Needle, 27G, 12 mm, 40 cm Tube EUDAMED
- Device Name
- Safety Subcutaneous Infusion Set EUDAMED
- Model / Reference
- 418460 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18859299148462 EUDAMED
- Basic UDI-DI
- 88592991B013UB EUDAMED
- EMDN Code
- A01010201 BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Safety Subcutaneous Infusion Set 1 Needle, 27G, 12 mm, 40 cm Tube by Epic International (Thailand) Co., Ltd. — Class IIb — 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 | 88592991B013UB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Epic International (Thailand) Co., Ltd.
- EUDAMED SRN
- TH-MF-000012102
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED b5b170ff-f922-4ab0-b7fd-80940567bbad 61 fields · synced Aug 3, 2026