Identity
- Trade Name
- Poly-Tape 10mm x 500mm EUDAMED
- Device Name
- Poly-Tape 10 x 500mm EUDAMED
- Model / Reference
- 102-1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060267132710 EUDAMED
- Basic UDI-DI
- B-05060267132710 EUDAMED
- EMDN Code
- P0999 ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Poly-Tape 10mm x 500mm by Xiros Limited — Class IIb — 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-05060267132710 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Xiros Limited
- EUDAMED SRN
- GB-MF-000004396
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 73d48844-6891-47e3-b704-c3eb2f575a79 61 fields · synced Jun 17, 2026