Identity
- Trade Name
- MONOSTEEL EUDAMED
- Device Name
- MONOFILAMENT STAINLESS STEEL 316 LVM Suture EUDAMED
- Model / Reference
- 16B90DY20H EUDAMED16F90DY32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904300120890 EUDAMED
- Basic UDI-DI
- 890430012015ULSSS0134Q EUDAMED
- EMDN Code
- H010202010101 STAINLESS STEEL MONOFILAMENT WITH NEEDLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Monosteel by Unisur Lifecare Private Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 890430012015ULSSS0134Q | Class IIb | 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 01326d85-63d2-425b-8afb-2513506c4427 61 fields · synced Jun 20, 2026