Identity
- Trade Name
- TorqMax Sheath Grip Accessory EUDAMED
- Device Name
- TorqMax Sheath Grip Accessory EUDAMED
- Model / Reference
- 502-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20813132020440 EUDAMED
- Basic UDI-DI
- B-20813132020440 EUDAMED
- EMDN Code
- Y241899 ARM, HAND, FINGER FUNCTION AID AND/OR SUBSTITUTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
TorqMax Sheath Grip Accessory by Spectranetics Corporation — Class I — 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-20813132020440 | Class I | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (1)
- EUDAMED 12b0541d-4e42-4e11-b1fd-8b7af4739e9d 61 fields · synced Jun 19, 2026