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Enter Medical Corporation

Chiayi County, TW

ENTER MEDICAL CORPORATION appears in FDA device records in Chiayi County, TW. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Enter Medical Corporation in 2005.

Clearances by year, as a table
510(k) clearance decisions for Enter Medical Corporation, by decision year
YearClearances
20051
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K042556SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,BTMSubstantially Equivalent

Registered establishments

FDA registered establishments for Enter Medical Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30039026793003902679ENTER MEDICAL CORPORATIONNo. 66-5, Yao Tzu Chu, Tsai Kung Village, Chiayi County Chiayi(County) 61642 TW2026and 11 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain