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Nylon Suture
EUDAMEDClass IIb (EU MDR)
Ref 10R53 11-0NRef 7R33 12-0NRef 10R43 10-0NRef 3R23 12-0NRef 14R33 8-0NRef 10R33 9-0NRef 7R43 11-0NRef 5R23 11-0NRef 10R54 11-0NRef 10R43 9-0NRef 10R43 11-0NRef 20T53 8-0NRef 7R23 12-0NRef 5R33 12-0NRef 7R33 11-0NRef 7R43 12-0N
Identity
- Device Name
- Nylon Suture EUDAMED
- Model / Reference
- 10R53 11-0N EUDAMED7R33 12-0N EUDAMED10R43 10-0N EUDAMED3R23 12-0N EUDAMED14R33 8-0N EUDAMED10R33 9-0N EUDAMED7R43 11-0N EUDAMED5R23 11-0N EUDAMED10R54 11-0N EUDAMED10R43 9-0N EUDAMED10R43 11-0N EUDAMED20T53 8-0N EUDAMED7R23 12-0N EUDAMED5R33 12-0N EUDAMED7R33 11-0N EUDAMED7R43 12-0N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 34946279743767 EUDAMED34946279743675 EUDAMED34946279745280 EUDAMED34946279745662 EUDAMED34946279746669 EUDAMED34946279746652 EUDAMED34946279743736 EUDAMED34946279743712 EUDAMED34946279743774 EUDAMED34946279745273 EUDAMED34946279743750 EUDAMED34946279746959 EUDAMED34946279743668 EUDAMED34946279743651 EUDAMED34946279743705 EUDAMED34946279743682 EUDAMED
- Basic UDI-DI
- B-34946279743767 EUDAMEDB-34946279743675 EUDAMEDB-34946279745280 EUDAMEDB-34946279745662 EUDAMEDB-34946279746669 EUDAMEDB-34946279746652 EUDAMEDB-34946279743736 EUDAMEDB-34946279743712 EUDAMEDB-34946279743774 EUDAMEDB-34946279745273 EUDAMEDB-34946279743750 EUDAMEDB-34946279746959 EUDAMEDB-34946279743668 EUDAMEDB-34946279743651 EUDAMEDB-34946279743705 EUDAMEDB-34946279743682 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-34946279743767 | 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 (16)
- EUDAMED 0481bca6-de1a-472a-bb27-0de85b653a4e 61 fields · synced Oct 6, 2026
- EUDAMED a087037c-a4aa-4023-9575-1ac889c2cf60 61 fields · synced May 11, 2026
- EUDAMED d546232b-be81-4257-8825-73b488b5fefe 61 fields · synced May 16, 2026
- EUDAMED 50bc81fc-52a9-4b3e-9e15-84367d46e95c 61 fields · synced May 16, 2026
- EUDAMED 74f15333-89e8-4de6-ad3d-c3af7420263e 61 fields · synced May 16, 2026
- EUDAMED 7a7f50fc-3aeb-4cb4-bd9e-2825b82523a3 61 fields · synced May 17, 2026
- EUDAMED de9d046f-1c40-4f7f-885b-de0bdac51f82 61 fields · synced May 17, 2026
- EUDAMED cb53f733-b8f6-4318-b11d-2b64594223bb 61 fields · synced May 17, 2026
- EUDAMED c5c5c377-adb4-4aa6-8b52-4f893f06647c 61 fields · synced May 17, 2026
- EUDAMED 0044ef27-eeb6-41ee-8648-c8c7040487c8 61 fields · synced May 17, 2026
- EUDAMED 1e588106-7e72-4abb-9dc9-252f754a8072 61 fields · synced May 17, 2026
- EUDAMED 616b9bc1-27ca-40b7-b49b-e32645155b15 61 fields · synced May 18, 2026
- EUDAMED c8ef0f96-a1db-4573-81b2-4be387695f57 61 fields · synced May 18, 2026
- EUDAMED 1fc0ae93-edb1-4374-a982-1e5f01d224a8 61 fields · synced May 19, 2026
- EUDAMED f157b25d-eb93-47c8-aded-5ac1e0eb6011 61 fields · synced May 19, 2026
- EUDAMED 8f623f78-00d0-4d7a-8946-ae318c09ce2f 61 fields · synced May 19, 2026