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Mani Sutures Nylon - 7-0 Nylon
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 40Ref 35
by Mani, Inc.
Identity
- Trade Name
- MANI SUTURES NYLON - 7-0 NYLON EUDAMEDMANI Sutures Nylon FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- MANI SUTURES NYLON EUDAMED
- Model / Reference
- 40 EUDAMEDFDA UDI35 EUDAMED
Identifiers
- Catalog Number
- 40 FDA UDI
- Primary DI / UDI-DI
- 04546951500344 EUDAMEDFDA UDI04546951633417 EUDAMED
- Basic UDI-DI
- B-04546951500344 EUDAMED4546951000006ZK EUDAMED
- FDA Product Code
- GAR FDA UDI
- EMDN Code
- H010201010101 POLYAMIDE MONOFILAMENT WITH NEEDLE EUDAMED
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5020 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 Nylon - 7-0 Nylon 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-04546951500344 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04546951500344 | 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 e3421a84-b362-41f4-978b-0e29e30ddfc0 61 fields · synced Jul 8, 2026
- FDA UDI ab0e297d-6bbc-4e82-9fdb-d5fb29b41388 33 fields · synced May 29, 2026
- EUDAMED e6ad3388-0a9d-41ed-9c54-30786d603475 61 fields · synced Jul 8, 2026