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Absorbable Surgical Suture With / Without Needle - PDO Suture
EUDAMEDClass III (EU MDR)
Ref PDS74024B0Model With / Without Needle
Identity
- Device Name
- Absorbable Surgical Suture With / Without Needle - PDO Suture EUDAMED
- Model / Reference
- With / Without Needle EUDAMEDPDS74024B0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938535553415 EUDAMED
- Basic UDI-DI
- B-06938535553415 EUDAMED
- EMDN Code
- H010101010101 POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland 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
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Absorbable Surgical Suture With / Without Needle - PDO Suture by Huaiyin Medical Instruments Co., Ltd. — Class III — MDD — listed in EUDAMED
Similar devices
Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
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- Maxon — Covidien LP · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
- DemeCAPRONE — DemeTECH Corp · Class II
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-06938535553415 | Class III | Active |
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Manufacturer
- Manufacturer
- Huaiyin Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000003351
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 6b69f2f0-5ee6-4b43-ad63-379f62a7d93f 61 fields · synced Jun 14, 2026