Identity
- Trade Name
- TRISTAN EUDAMED
- Device Name
- TR Filling Block EUDAMED
- Model / Reference
- 1501010003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250539934062 EUDAMED
- Basic UDI-DI
- 42505399340NA EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Surgical retraction system, reusable
Tristan by HumanTech Spine GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42505399340NA | Class I | Active |
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Manufacturer
- Manufacturer
- HumanTech Spine GmbH
- EUDAMED SRN
- DE-MF-000010596
Sources (1)
- EUDAMED b87a4177-b012-4a05-9d6d-611af3da8f8f 61 fields · synced Jul 9, 2026