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Tender Grip, Cannula fixation device
EUDAMEDClass I (EU MDR)
Ref 1005-0-25Model Skin Fixation Devices
by Salter Labs
Identity
- Trade Name
- Tender Grip, Cannula fixation device EUDAMED
- Model / Reference
- Skin Fixation Devices EUDAMED1005-0-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411001021 EUDAMED
- Basic UDI-DI
- 0607411TF20011_SkinFixAR EUDAMED
- Unit of Use DI
- 00607411001024 EUDAMED
- EMDN Code
- R03010280 OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES 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
Tender Grip, Cannula fixation device by Salter Labs, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0607411TF20011_SkinFixAR | Class I | Active |
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Manufacturer
- Manufacturer
- Salter Labs
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED a3e06b0e-f104-4af2-acba-3c6529e62521 61 fields · synced Oct 5, 2026