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Mani Sutures Polypropylene - 7-0 Polypropylene
EUDAMEDClass IIb (EU MDR)
Ref 3306SRef 3313SRef 3307SRef 3309
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES POLYPROPYLENE - 7-0 POLYPROPYLENE EUDAMED
- Device Name
- MANI SUTURES POLYPROPYLENE EUDAMED
- Model / Reference
- 3306S EUDAMED3313S EUDAMED3307S EUDAMED3309 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951404291 EUDAMED04546951405847 EUDAMED04546951404307 EUDAMED04546951404321 EUDAMED
- Basic UDI-DI
- B-04546951404291 EUDAMEDB-04546951405847 EUDAMEDB-04546951404307 EUDAMEDB-04546951404321 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-04546951404291 | 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 (4)
- EUDAMED 16a2d5b6-294c-4fa1-a7cb-0b12a8df4569 61 fields · synced Sep 18, 2026
- EUDAMED e2335337-cc71-46e9-865a-d46c1b1eee95 61 fields · synced May 17, 2026
- EUDAMED 4125e8f9-0ff3-444e-aab3-6cd2841dac34 61 fields · synced May 17, 2026
- EUDAMED 72ed5a45-8147-4c8c-969a-2e24a5fdb55c 61 fields · synced May 18, 2026