Identity
- Trade Name
- UNISYNTH PDS EUDAMED
- Device Name
- Monofilament Polydioxanone Suture EUDAMED
- Model / Reference
- 9E70DZ25 EUDAMED9G75DZ16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904300116343 EUDAMED
- Basic UDI-DI
- 890430012015ULSSS0094Z EUDAMED
- EMDN Code
- H010101010101 POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Unisynth Pds by Unisur Lifecare Private Limited — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
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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 | 890430012015ULSSS0094Z | Class III | Active |
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Manufacturer
- Manufacturer
- Unisur Lifecare Private Limited
- EUDAMED SRN
- IN-MF-000008184
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 7c10f353-fb21-4f0a-b445-87c2dc92d683 61 fields · synced Jun 20, 2026