DeRoyal

Cervical Collar, Capital Enhanced

Registry build 21.09.26
114manufacturers in China registered for this device type
554catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (30), Jiangsu (23), Zhejiang (17). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IQK
Manufacturer City Province Registered as Device types
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Fortune Company Ltd. Huizhou Guangdong Contract manufacturer 23
Allmay Bodywear (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 21
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18
Metacare Industrial Ltd Guangzhou Guangdong Contract manufacturer 17
IPE Plastic & Hardware Industy, Ltd Dongguan Guangdong Contract manufacturer 15
Yangzhou Feiyali Sporting Goods Co., Ltd. Yangzhou Jiangsu Contract manufacturer 15
Hengshui Tianjian Medical Supplies Co., Ltd. Shenzhou Hebei Contract manufacturer 14
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Jianxing Shoe Co., Ltd. Foshan Guangdong Contract manufacturer 11
Fenglin Industry Co., Ltd. Dongguan Guangdong Contract manufacturer 10

Showing 12 of 114. All 114 manufacturers in China registered for Orthosis, Cervical

Record

Regulatory record for DeRoyal
Listed by Deroyal Industries, Inc., United States
FDA product code IQK
Device type Orthosis, Cervical
Device class Class 1
Regulation 21 CFR 890.3490
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2026-04-02
Record revised 2022-06-10 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 6, case of 10, case of 12, case of 20, case of 30
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number Size Status
1113LPP In distribution
203N10 In distribution
14-101A-03 In distribution
11250000 In distribution
14-115A-01 In distribution
11239000 In distribution
11293000 In distribution
1030251 In distribution
14-106A-04 In distribution
26002 In distribution
14-117A-06 In distribution
14-109A-03 In distribution
1010-02 In distribution
11482000 In distribution
14-104A-05 In distribution
14-109A-05 In distribution
400N18 In distribution
11229000 In distribution
1105ASSPP In distribution
11551000 In distribution
11432000 In distribution
1061-04 In distribution
1002-03 In distribution
A9917-01 In distribution
1056-05 In distribution
19304 In distribution
11483003 In distribution
11501000 In distribution
26102 In distribution
1003-03 In distribution
26104 In distribution
11341000 In distribution
11311000 In distribution
1030-04 In distribution
203N30 In distribution
1044-41 In distribution
1010201 In distribution
11422000 In distribution
1057-04 In distribution
1005-03 In distribution
105N40 In distribution
A117007 In distribution
1010351 In distribution
11442000 In distribution
11552000 In distribution
11443000 In distribution
11281000 In distribution
A111900 In distribution
A111000 In distribution
1104MPP In distribution
11222000 In distribution
RC-525SM In distribution
1043-03 In distribution
A115005 In distribution
26004 In distribution
11249000 In distribution
400N13 In distribution
11333000 In distribution
14-117A-00 In distribution
11-10525 In distribution
14-109A-01 In distribution
1050-14 In distribution
19305 In distribution
1050-11 In distribution
1103LPP In distribution
1005-33 In distribution
1056-02 In distribution
1034-12 In distribution
1005-22 In distribution
400N15 In distribution
1040401 In distribution
406N26 In distribution
1003-01 In distribution
1057-00 In distribution
14-109A-04 In distribution
1044-80 In distribution
1054-13 In distribution
TX9920-13 In distribution
1050-31 In distribution
1034-53 In distribution
1024-52 In distribution
14-10225 In distribution
204N20 In distribution
1044-82 In distribution
11471000 In distribution
11481001 In distribution
11571000 In distribution
11561000 In distribution
406N16 In distribution
11483002 In distribution
299N10 In distribution
1023-01 In distribution
11-10425 In distribution
14-100A-04 In distribution
RC-225XL In distribution
1044-14 In distribution
RC-425MD In distribution
1006-03 In distribution
20200 In distribution
300N10 In distribution
1005-55 In distribution
1000351 In distribution
1043-00 In distribution
11421000 In distribution
26105 In distribution
14-100A-03 In distribution
TX9916-12 In distribution
1034-13 In distribution
400N12 In distribution
106N10 In distribution
A116006 In distribution
A9918-13 In distribution
14-101A-01 In distribution
1061-05 In distribution
1056-00 In distribution
1010251 In distribution
1050-02 In distribution
A9918-11 In distribution
1105ASPP In distribution
A9919-14 In distribution
TX9919-11 In distribution
11226000 In distribution
14-101A-02 In distribution
1054-53 In distribution
1056-03 In distribution
12-10525 In distribution
1103ADPP In distribution
1011-12 In distribution
100N21 In distribution
11462000 In distribution
1044-61 In distribution
1054-52 In distribution
400N11 In distribution
205N20 In distribution
14-115A-03 In distribution
11291000 In distribution
13-10525 In distribution
1023-00 In distribution
1024-14 In distribution
1043-04 In distribution
1044-11 In distribution
1063-02 In distribution
1001-01 In distribution
1050-13 In distribution
RC-PED In distribution
RC-325LG In distribution
1105CRPP In distribution
1061-03 In distribution
11483001 In distribution
1050-10 In distribution
11261000 In distribution
11245000 In distribution
14-104A-02 In distribution
11263000 In distribution
1020251 In distribution
11521000 In distribution
1024-53 In distribution
499N41 In distribution
14-102A-05 In distribution
14-108A-05 In distribution
1030-05 In distribution
204N30 In distribution
1057-03 In distribution
1044-85 In distribution
11258000 In distribution
RC-525LG In distribution
1004-01 In distribution
A9918-14 In distribution
1057-01 In distribution
1001-03 In distribution
11221000 In distribution
1020301 In distribution
14-104A-04 In distribution
1018-01 In distribution
498N42 In distribution
1054-12 In distribution
14-115A-04 In distribution
11582000 In distribution
204N40 In distribution
1040351 In distribution
400N14 In distribution
14-106A-02 In distribution
1044-13 In distribution
A9917-00 In distribution
1001-04 In distribution
1001-05 In distribution
497N43 In distribution
11265000 In distribution
11481000 In distribution
1007-02 In distribution
11241000 In distribution
1024-13 In distribution
1050-33 In distribution
11242000 In distribution
11275000 In distribution
13-10325 In distribution
103N20 In distribution
RC-425XL In distribution
11441000 In distribution
RC-325SM In distribution
11202000 In distribution
1044-60 In distribution
1050-34 In distribution
14-102A-00 In distribution
1002-02 In distribution
11200000 In distribution
11-10225 In distribution
TX9920-11 In distribution
11532000 In distribution
11271000 In distribution
11282000 In distribution
1006-02 In distribution
1057-02 In distribution
11482001 In distribution
205N30 In distribution
1010401 In distribution
14-103A-00 In distribution
402N22 In distribution
A9918-12 In distribution
11301000 In distribution
1102MPP In distribution
1040251 In distribution
11224000 In distribution
A117005 In distribution
14-103A-98 In distribution
11483000 In distribution
404N14 In distribution
401N12 In distribution
1005-02 In distribution
1043-01 In distribution
19303 In distribution
1023-50 In distribution
1105CRSPP In distribution
1018-05 In distribution
1044-83 In distribution
26003 In distribution
14-100A-01 In distribution
11302000 In distribution
1043-02 In distribution
RC-525MD In distribution
1103MPP In distribution
11433000 In distribution
11253000 In distribution
11216000 In distribution
1050-01 In distribution
14-109A-02 In distribution
20704 In distribution
11331000 In distribution
11481003 In distribution
1000401 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cervmax® PMT Corp. 191
Breg Breg, Inc. 26
Orthosis, Cervical Tetra Medical Supply Corp. 21
Wellbrace Pantymed S.A. 18
Two Piece Collar w/Trach Bird & Cronin, LLC 15
Cervical Collar Dynarex Corp. 14
Vive Vive Health LLC 14
Spencer Spencer Italia SRL 13
Perfit Collar™ Ambu A/S 12
Push braces Nea International B.V. 8
DR-HOS Guangzhou Xinbo Electronic Co., Ltd. 5
Restcloud Chengdu Si Hai Mu Ze Technology Co., Ltd. 5

Showing 12 of 107. All products under Orthosis, Cervical

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer