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Mani Sutures Nylon - 10-0 Nylon
EUDAMEDClass IIb (EU MDR)
Ref 1430
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES NYLON - 10-0 NYLON EUDAMED
- Device Name
- MANI SUTURES NYLON EUDAMED
- Model / Reference
- 1430 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951404567 EUDAMED
- Basic UDI-DI
- B-04546951404567 EUDAMED
- EMDN Code
- H010201010101 POLYAMIDE MONOFILAMENT WITH NEEDLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Mani Sutures Nylon - 10-0 Nylon by Mani, Inc. — 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-04546951404567 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 3a806760-c320-4ff5-910b-9e4d0124d97f 61 fields · synced Jun 18, 2026