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Mani Sutures Silk - 5-0 Silk
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 30Ref 4350S
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES SILK - 5-0 SILK EUDAMEDMANI Sutures Silk FDA UDI
- Generic Name
- Silk suture FDA UDI
- Device Name
- MANI SUTURES SILK EUDAMED
- Model / Reference
- 30 EUDAMEDFDA UDI4350S EUDAMED
Identifiers
- Catalog Number
- 30 FDA UDI
- Primary DI / UDI-DI
- 04546951500238 EUDAMEDFDA UDI04546951635176 EUDAMED
- Basic UDI-DI
- B-04546951500238 EUDAMED4546951000004ZF EUDAMED
- FDA Product Code
- GAP FDA UDI
- EMDN Code
- H010202020301 SILK WITH NEEDLE EUDAMED
- GMDN Term
- Silk suture FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5030 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
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
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
No
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 Silk - 5-0 Silk by Mani, Inc. — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04546951500238 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04546951500238 | 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 (3)
- EUDAMED a7543ad5-2c2a-4c49-a20b-185aff6fe213 61 fields · synced Aug 1, 2026
- FDA UDI 04fb36d4-6628-49f4-84bb-02f3e22c0ff4 33 fields · synced May 30, 2026
- EUDAMED f98c0cf9-c00c-4069-8fa5-85303be2bd47 61 fields · synced Aug 1, 2026