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Mani Sutures Polyester - 5-0 Polyester
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 3375
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES POLYESTER - 5-0 POLYESTER EUDAMEDMANI Sutures Polyester FDA UDI
- Generic Name
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
- Device Name
- MANI SUTURES POLYESTER EUDAMEDMANI Ophthalmic Sutures FDA UDI
- Model / Reference
- 3375 EUDAMEDFDA UDI
- Description
- MANI Ophthalmic Sutures FDA UDI
Identifiers
- Catalog Number
- 3375 FDA UDI
- Primary DI / UDI-DI
- 04546951400750 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951400750 EUDAMED
- FDA Product Code
- GAT FDA UDI
- EMDN Code
- H010201020201 POLYESTER MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
- GMDN Term
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5000 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mani Sutures Polyester - 5-0 Polyester by Mani, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04546951400750 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 99c9a0bb-70e3-4874-bf9b-bb60f4e6df3b 61 fields · synced Jun 18, 2026
- FDA UDI 99ad6a36-e938-4814-89e9-cac448e08e0e 35 fields · synced May 30, 2026