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Mani Sutures Polypropylene - 6-0 Polypropylene
EUDAMEDClass IIb (EU MDR)
Ref 3310SRef 3312Ref 3316S
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES POLYPROPYLENE - 6-0 POLYPROPYLENE EUDAMED
- Device Name
- MANI SUTURES POLYPROPYLENE EUDAMED
- Model / Reference
- 3310S EUDAMED3312 EUDAMED3316S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951404338 EUDAMED04546951404352 EUDAMED04546951405885 EUDAMED
- Basic UDI-DI
- B-04546951404338 EUDAMEDB-04546951404352 EUDAMEDB-04546951405885 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 - 6-0 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-04546951404338 | 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 (3)
- EUDAMED 3376425b-def7-42ea-a290-df08e02c71f8 61 fields · synced Jul 20, 2026
- EUDAMED 172604a5-bf9e-43ff-b0e6-9c1bf3de7c0e 61 fields · synced May 19, 2026
- EUDAMED 6b89da23-64c6-440f-a728-02bd03699f0e 61 fields · synced May 19, 2026