Temp. Skin Probe 1.5M Reusable
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- PROBE 1,SKIN TEMP,REUSABLE EUDAMEDHAUTTEMP.SONDE 1,5M, MEHRWEG EUDAMEDTemp. Skin Probe 1.5M Reusable FDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Model / Reference
- 4329822 EUDAMEDFDA UDI038003 EUDAMEDMU06951 EUDAMED207018VK19X010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098009300 EUDAMEDFDA UDI04049098038003 EUDAMED
- Basic UDI-DI
- B-04049098038003 EUDAMED040486752207018VK19X010EW EUDAMED
- Direct Marketing DI
- 04049098009300 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- Z1208040302 MOBILE NEONATAL INCUBATORS EUDAMEDZ1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose patient temperature probe, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose patient temperature probe, reusable
Temp. Skin Probe 1.5M Reusable by Draeger Medical Systems, Inc. — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (3)
- FDA UDI a077b387-c157-4db6-aaa4-77ebe0d67bf7 33 fields · synced Jul 10, 2026
- EUDAMED 44ceb277-9b16-479e-a5ce-e88f1a3671ea 61 fields · synced Jul 10, 2026
- EUDAMED f12eb2ea-a47b-42e2-9315-924e069a8755 61 fields · synced Jul 10, 2026