for prescription use only

Romanian translation: exclusiv utilizării pe bază de prescripție medicală

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:for prescription use only
Romanian translation:exclusiv utilizării pe bază de prescripție medicală
Entered by: danieline

18:08 Nov 8, 2023
English to Romanian translations [PRO]
Medical - Medical: Instruments
English term or phrase: for prescription use only
The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.
danieline
Local time: 13:59
exclusiv utilizării pe bază de prescripție medicală
Explanation:
· Dispozitivul este destinat exclusiv utilizarii pe baza de prescriptie medicala.
Selected response from:

Iosif JUHASZ
Romania
Local time: 13:59
Grading comment
Multumesc!
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +3exclusiv utilizării pe bază de prescripție medicală
Iosif JUHASZ
Summary of reference entries provided
pot fi achiziționate doar pe bază de rețetă
Manuela C.

  

Answers


4 mins   confidence: Answerer confidence 5/5 peer agreement (net): +3
exclusiv utilizării pe bază de prescripție medicală


Explanation:
· Dispozitivul este destinat exclusiv utilizarii pe baza de prescriptie medicala.


    https://steris.ro/sistem-monitorizare-continua-glicemica-cgm.html
Iosif JUHASZ
Romania
Local time: 13:59
Specializes in field
Native speaker of: Native in HungarianHungarian, Native in RomanianRomanian
PRO pts in category: 48
Grading comment
Multumesc!

Peer comments on this answer (and responses from the answerer)
agree  Manuela C.
13 mins
  -> Mulțumesc!

agree  Angela Bostan
54 mins
  -> Mulțumesc!

agree  Ana-Maria Badea
14 hrs
Login to enter a peer comment (or grade)




Reference comments


18 mins peer agreement (net): +1
Reference: pot fi achiziționate doar pe bază de rețetă

Reference information:
if the device is for prescription use only, then the symbol (or narrative analog) is a regulatory requirement. Failure to have it when required will result in the device being misbranded (i.e., not legally labeled).
https://www.fda.gov/about-fda/economic-impact-analyses-fda-r...
Type of Use (Select one or both, as applicable)
 Prescription Use (Part 21 CFR 801 Subpart D)
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192137.pdf

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Note added at 57 mins (2023-11-08 19:05:26 GMT)
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Da, se aplică și la dispozitive
de exemplu un tensiometru sau un termometru este over-the-counter, se achiziționează liber

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Note added at 1 hr (2023-11-08 19:08:22 GMT)
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De exemplu aici:
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192137.pdf
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
este bifata casuta
 Prescription Use (Part 21 CFR 801 Subpart D)

Manuela C.
Native speaker of: Native in RomanianRomanian
PRO pts in category: 32
Note to reference poster
Asker: Sunt niste monitoare de functii vitale.

Asker: Multumesc pentru explicatii.


Peer comments on this reference comment (and responses from the reference poster)
agree  Angela Bostan
41 mins
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