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1.5 Tension Sleeve for M-2512
EUDAMEDClass I (EU MDR)
Ref M-2552
by Medartis AG
Identity
- Trade Name
- 1.5 Tension Sleeve for M-2512 EUDAMED
- Device Name
- Guides EUDAMED
- Model / Reference
- M-2552 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630894821400 EUDAMED
- Basic UDI-DI
- 76300378007PE 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
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
Category: Surgical retraction system, reusable
1.5 Tension Sleeve for M-2512 by Medartis AG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical retraction system, reusable.
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- 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 | 76300378007PE | Class I | Active |
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Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (1)
- EUDAMED 95d5e0e8-6b9d-4aad-ac7b-a3be30101dd3 61 fields · synced Jul 10, 2026