Identity
- Trade Name
- Poly-Tape 10 x 800mm EUDAMEDPoly-Tape 10 mm x 800 mm FDA UDI
- Generic Name
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
- Device Name
- Poly-Tape 10 x 800mm EUDAMED
- Model / Reference
- 102-1080 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- n/a FDA UDI
- Primary DI / UDI-DI
- 05060267130471 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060267130471 EUDAMED
- 510(k) Number
- K010051 FDA UDI
- FDA Product Code
- JDR FDA UDI
- EMDN Code
- P0999 ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER EUDAMED
- GMDN Term
- Polyester suture, non-bioabsorbable, multifilament FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Slovenia 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
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
Prescription Use
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Poly-Tape 10 x 800mm by Xiros Limited — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060267130471 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Xiros Limited
- EUDAMED SRN
- GB-MF-000004396
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 0667ee52-2bd0-4d7e-8a95-8719f25616f1 61 fields · synced Jul 25, 2026
- FDA UDI 7ccb9aff-c68a-4494-8adf-746bb0a46f13 35 fields · synced May 30, 2026