Identity
- Trade Name
- ADVALENE EUDAMED
- Device Name
- ADVALENE-Non absorbable Surgical Suture U.S.P. Monofilament Polypropylene Blue Sterilized Surgical Suture EUDAMED
- Model / Reference
- USP size 1,0,2-0,3-0,4-0,5-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-89042724ADVALENEXY29 EUDAMED
- Basic UDI-DI
- B-89042724ADVALENEXY29 EUDAMED
- EMDN Code
- H010201010401,H010201010403 EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Advalene by Advanced MedTech Solutions Private Limited — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-89042724ADVALENEXY29 | Class III | Active |
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Manufacturer
- Manufacturer
- Advanced MedTech Solutions Private Limited
- EUDAMED SRN
- IN-MF-000016196
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 06ec3217-59ae-498a-98d2-2310d808c5cb 61 fields · synced Jun 18, 2026
- EUDAMED 06ec3217-59ae-498a-98d2-2310d808c5cb-1 61 fields · synced Jun 10, 2026