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SLS 600i
EUDAMEDFDA UDIClass I (EU MDR)
Ref SLS600iModel Safe Label System Point of Care
Identity
- Trade Name
- SLS 600i EUDAMEDCodonics Safe Label System®(SLS) 600i Point of Care Station - 170C FDA UDI
- Generic Name
- Anaesthesia unit, mobile FDA UDI
- Device Name
- SLS 500i EUDAMEDSafe Label System automated barcode scan and labeling RFID CoAx ready 170C FDA UDI
- Model / Reference
- Safe Label System Point of Care EUDAMEDSLS600i EUDAMED600i PCS FDA UDI
- Description
- Safe Label System automated barcode scan and labeling RFID CoAx ready 170C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814905021103 EUDAMEDFDA UDI
- Basic UDI-DI
- 081490502SLSPCS01XR EUDAMED
- Direct Marketing DI
- 00814905021103 EUDAMED
- 510(k) Number
- K101439 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- EMDN Code
- A0704 SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS EUDAMED
- GMDN Term
- Anaesthesia unit, mobile FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SLS 600i by Codonics Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081490502SLSPCS01XR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Codonics Inc.
- EUDAMED SRN
- US-MF-000008190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 5b7a7759-92f6-49ab-9621-cb38c0e633a2 61 fields · synced Jun 18, 2026
- FDA UDI 3b4fc697-162b-4118-b2e3-b05224dcd9fd 35 fields · synced May 29, 2026