← Back to catalogue
Mani Sutures Polyester - 4-0 Polyester
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 4356
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES POLYESTER - 4-0 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
- 4356 EUDAMEDFDA UDI
- Description
- MANI Ophthalmic Sutures FDA UDI
Identifiers
- Catalog Number
- 4356 FDA UDI
- Primary DI / UDI-DI
- 04546951402785 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951402785 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 - 4-0 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-04546951402785 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 3bb9be5d-d0a1-47ee-a518-ed297e51915b 61 fields · synced Jul 27, 2026
- FDA UDI 1c775452-bd41-4b27-9d0a-8a8aea89bc02 35 fields · synced May 30, 2026