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FortiTex Suture, USP #2, white/ blue, needle
EUDAMEDClass IIb (EU MDR)
Ref 100.357
by 41medical AG
Identity
- Trade Name
- FortiTex Suture, USP #2, white/ blue, needle EUDAMED
- Device Name
- Suture EUDAMED
- Model / Reference
- 100.357 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640185670501 EUDAMED
- Basic UDI-DI
- 764018567000001JD EUDAMED
- Unit of Use DI
- 07640185670464 EUDAMED
- EMDN Code
- H0102010299 SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - OTHER 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
Sutures
Yes
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
Category: Polyester suture, non-bioabsorbable, multifilament
FortiTex Suture, USP #2, white/ blue, needle by 41medical AG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018567000001JD | Class IIb | Active |
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Manufacturer
- Manufacturer
- 41medical AG
- EUDAMED SRN
- CH-MF-000016966
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (1)
- EUDAMED f607ad97-9316-4f21-aee8-45526153bff5 61 fields · synced Jul 21, 2026