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Regula Normmed Maxifiber Suture
EUDAMEDClass IIb (EU MDR)
Ref NMKA0802Ref NMKA0801Ref NMKA0806Ref NMKA0803Ref NMKA0805
Identity
- Trade Name
- REGULA NORMMED MAXIFIBER SUTURE EUDAMEDREGULA NORMMED MAXIFIBER SUTURE EUDAMED
- Device Name
- REGULA NORMMED MAXIFIBER SUTURE EUDAMEDREGULA NORMMED MAXIFIBER SUTURE EUDAMED
- Model / Reference
- NMKA0802 EUDAMEDNMKA0801 EUDAMEDNMKA0806 EUDAMEDNMKA0803 EUDAMEDNMKA0805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682549594268 EUDAMED08682549594251 EUDAMED08682549594305 EUDAMED08682549594275 EUDAMED08682549594299 EUDAMED
- Basic UDI-DI
- B-08682549594268 EUDAMEDB-08682549594251 EUDAMEDB-08682549594305 EUDAMEDB-08682549594275 EUDAMEDB-08682549594299 EUDAMED
- EMDN Code
- H0102010299 SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Polyester suture, non-bioabsorbable, multifilament
Regula Normmed Maxifiber Suture by Normmed Medi̇kal San. Ve Ti̇c. A.ş. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Polyester suture, non-bioabsorbable, multifilament.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08682549594268 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Normmed Medi̇kal San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000015713
Sources (5)
- EUDAMED 6251a0d0-a029-4108-83ce-449fd7cc280e 61 fields · synced Sep 17, 2026
- EUDAMED 691aa6ea-2782-48fa-a647-cefd9f26bd7a 61 fields · synced May 16, 2026
- EUDAMED 6924ddf3-5bd4-4256-b179-6eede069ea51 61 fields · synced May 17, 2026
- EUDAMED e76c3dc2-96e3-48e8-8ded-31f8c6392c67 61 fields · synced May 17, 2026
- EUDAMED cbbb71b6-7ff7-4f6a-890d-f9edd0ecdc12 61 fields · synced May 18, 2026