Identity
- Device Name
- Nylon Suture EUDAMED
- Model / Reference
- 5R33 11-0N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 34946279743699 EUDAMED
- Basic UDI-DI
- B-34946279743699 EUDAMED
- EMDN Code
- H010201010101 POLYAMIDE MONOFILAMENT WITH NEEDLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nylon Suture by Keisei Medical Industrial 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-34946279743699 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Keisei Medical Industrial Co., Ltd.
- EUDAMED SRN
- JP-MF-000021775
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 5021478f-e807-4a7c-b8ec-79deab5eae13 61 fields · synced Jun 18, 2026