Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010509576

FEI Number

3010509576

Entity Name

Caretek(China) Medical PLC

City/State/Country

Guangzhou City Guangdong, CN

Establishment Address

Xiguakeng, Guanqiao Village, Shilou Town, Panyu District, Guangzhou City Guangdong 511447, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Caretek (China) Medical PLC (Owner Number: 10045102)

Owner / Operator Contact Address

Xiguakeng, Guanqiao Village, Shilou Town, Panyu District, Guangzhou City, CN-GD 511447, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CareTEK Mobile Patient Lifting System Monarch, Monarch01, 1660543, 1655981, 1650163, 1650164, 1650165, 1650166, 1656650, PLS01, PLF01, PLW01 Optional accessories:Step(COU73/WHITE-CBL, COU78/WHITE-CBL) ,STEP-02) ME201, ME220, ME320, ME321, ME322, ME323, Caretek Electric Backrest Couch Caretek Couch, EE120, EE220, EE320, EP120, EP220, EP320, PE120, PE220, PE320 MT210, MT211, MT110, MT111, MT112, KT110, KT111, HT110, HT111, ST110, ST111, CT110, CT111 , TT110,TT111 Caretek Overbed Table,Prioma Overbed Table, L100, LS100, LS102, LP100, LP110, LS103,KT21 HT110P, HT110P-BLUE, KT110P, KT110P-BLUE, MT110P, MT110P-BLUE, 200CS 'C' Size Oxygen Bottle Holder(CTKO2), GB320-CD-10, GB320-CD-11 GB320, GB320-IND,KTK-XLC-D/ZL-2S, KTK-XLC-D/ZL-1S, KTK-XLC-D/ZL-1, KTK-XLC-D/ZL-2, KTK-XLC-D/ZL-3 'C' Size Oxygen Bottle Holder(CTKO2) ; IV Pole (IVDMR506, IV-Pole, IV110, IV112, IVP-SA, IVP-SA-L) MA150C-A ,MA125C,MA125C-A,MA1250, MAP120),'CSize Oxygen Bottle Holder(cTK02) V420A MA-CZ-ET,K105-96-CD,K106-CD,K105-96-CD-Z,MA108,MA150,MAS150,MA150C,MA1500 IV Pole (IVDMR506, IV-Pole, IV110,IV112,IVP-SA, IVP-SA-L),X-Ray Cassette Holder (CTKXCAS), Self Help Pole(SP001, SP002) MA-CZ-ET,K105-96-CD,K106-CD,K105-96-CD-Z, MA108, MA150, MAS150, MA150C, MA150Q, MA150C-A ,MA125C,MA125C-A,MA125Q, MAP120 M420-98A,M420-66,M165,M165-KS,Minuet, Omega,Prioma Medical Bed, Prioma 400 Bed, Prioma 500 Bed,Prioma 600 Bed , Prioma X-Ray Cassette Holder (CTKXCAS); Self Help Pole(SP001, SP002) G420-90A,G420-P43, G420-P53, G420-P63, G420-P5F, G420-98, G420-98A, G420-66, G420-66A KTK-XLC-D/ZL-4, L420-06S, L420-06, L420-08S, L420-08, L420-18S, L420-18, L420-98S, L420-98,M420, M420-01, M420-02 E420, E420-S, E420-F, E420-28, E420-88, E5100, E5100-S, E5100-F, E5100-28, E5100-88, G420-28, G420-68, G420-88 M420-08, M420-18, M420-18CT, M420-51CT,M420-98CT,M420-98CTE,M420-98S,M420-98SE,M420-33,M420-33AT,M420-33CT Birthing Bed, PBB2, Prioma LTC40 Long Term Care Bed , Serrento,T420, W420-06,W420-08, W420-88, V420-S,V420-SA,V420 Optional accessories: Mattress(MA084, MA101, MA121, MA08-03, K100-CD,K101-CD, GB320-CD-10, GB320-CD-11 Prioma BB1 Birthbed,GB310,E1000 X-Ray Cassette Holder (CTKXCAS); Self Help Pole(SP001, SP002) M410-98,M410-98-PA,M410-88-LG,M410-88HL,M410-88PF ,MST110,T600,T600P IV Pole (IVDMR506, IV-Pole, IV110, IV112, IVP-SA, IVP-SA-L) B400-88G2,B400-88N,B400-88N-W870,B400-98,B400-98-C,B400-98N,B400-98N-C,B400-98-PA B400-W870-A,D300,D310,E410,M410,M410-01,M410-02,M410-02G2,M410-05,M410-07 Caretek Manual Bed,S100,A200,B200-88,B200-88N,B400,B400-10-68,B400-10-68N,B400-10-88,B400-10-88N K103-CD,MA-CZ-ET,K105-96-CD,K106-CD,K105-96-CD-Z, MA108, MA150, MAS150, MA150C, MA150Q B400-10-98,B400-10-98N,B400-18.B400-18-B,B400-18N,B400-26, B400-58,B400-58N,B400-68,B400-68N,B400-88 K121,N100,N101,N110,N102,N103,N104,N105,Prioma Medical Bed O510,O511,O512,O513,O514,O504,O505,K100,K101,K102,K103,K104,K105,K106,K107,K108,K109,K111N,K112,K112N MA150C-A ,MA125C,MA125C-A,MA125Q, MAP120);'C' Size Oxygen Bottle Holder(CTKO2)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2021-09-22
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2013-10-21
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2013-10-21
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2013-10-21
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2013-10-21

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Caretek (China) Medical PLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010509576. Last updated year: 2026. Please use registration number 3010509576 when referencing this establishment in official correspondence.