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Mani Sutures Polypropylene - 7-0 Polypropylene
EUDAMEDClass IIb (EU MDR)
Ref 3314
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES POLYPROPYLENE - 7-0 POLYPROPYLENE EUDAMED
- Device Name
- MANI SUTURES POLYPROPYLENE EUDAMED
- Model / Reference
- 3314 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951405854 EUDAMED
- Basic UDI-DI
- B-04546951405854 EUDAMED
- EMDN Code
- H010201010401 POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY 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 Polypropylene - 7-0 Polypropylene 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-04546951405854 | 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 458bce27-775b-4733-962d-2c8a85490a27 61 fields · synced Jun 17, 2026