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Reusable Pulse Oximetry Sensor System with EMBLA 8000J
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 2353-003Model EMBLA 8000J 3M, EMBLA P/N 1431002
Identity
- Trade Name
- Reusable Pulse Oximetry Sensor System with EMBLA 8000J EUDAMEDRESUSABLE PULSE OXIMETRY SENSOR SYSTEM FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- Reusable Pulse Oximetry Sensor System with EMBLA 8000J EUDAMEDRESUSABLE PULSE OXIMETRY SENSOR SYSTEM with 8000J 3M FDA UDI
- Model / Reference
- EMBLA 8000J 3M, EMBLA P/N 1431002 EUDAMED2353-003 EUDAMEDEMBLA 8000J 3M FDA UDI
- Description
- RESUSABLE PULSE OXIMETRY SENSOR SYSTEM with 8000J 3M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00833166004410 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00833166004410 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Pulse oximeter probe, single-use
Reusable Pulse Oximetry Sensor System with EMBLA 8000J by Nonin Medical, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Pulse oximeter probe, single-use.
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- M-LNCS — MASIMO CORPORATION · Class II
- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00833166004410 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Nonin Medical, Inc.
- EUDAMED SRN
- US-MF-000008228
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED e84ee4ee-2f22-47ae-acd8-67d203e38aee 61 fields · synced Jul 16, 2026
- FDA UDI e28d4622-b398-403d-ab36-c3837a9ce77f 33 fields · synced May 30, 2026