Identity
- Trade Name
- 5mm PretzelFlex Sterilisation Sleeve EUDAMED
- Device Name
- 5mm PretzelFlex Sterilisation Sleeve EUDAMEDPretzelflex Sterilization Sleeve EUDAMED
- Model / Reference
- SHR2024-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051986013435 EUDAMED
- Basic UDI-DI
- B-05051986013435 EUDAMED5051986SIRUS54 EUDAMED
- Direct Marketing DI
- 05051986013435 EUDAMED
- EMDN Code
- L1280 LAPAROSCOPIC AND THORACOSCOPIC SURGERY INSTRUMENTS, REUSABLE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
5mm PretzelFlex Sterilisation Sleeve by Surgical Innovations Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05051986013435 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05051986013435 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Surgical Innovations Ltd.
- EUDAMED SRN
- GB-MF-000012187
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED 772efd37-0a45-41b1-9026-b4fff5d4bbaf 61 fields · synced Sep 30, 2026
- EUDAMED ceb81642-931d-44ad-9db7-5ba183c58f03 61 fields · synced May 19, 2026