Amoena
The Amoena Custom Breast Form is individually designed and manufactured according the individual needs of each patient.
2manufacturers in China registered for this device type
230catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Nanning Sixtant Biotechnology Co., Ltd. | Nanning | Guangxi | Manufacturer | 13 |
Record
| Listed by | Amoena Medizin-Orthopädie-Technik GmbH |
|---|---|
| FDA product code | KCZ |
| Device type | Prosthesis, Breast, External, Used With Adhesive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3800 |
| Premarket notification | Exempt |
| Record published | 2023-10-09 |
| Record revised | 2025-12-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 139 Nipple Set tawny large | 2 | In distribution | |
| 386T Contact 3 E, TW 06 R | In distribution | ||
| 383 Contact 2A, 03 L | In distribution | ||
| 386T Contact 3 E, TW 05 R | In distribution | ||
| 386T Contact 3 E, TW 01 R | In distribution | ||
| 286 Balance Contact SV, S | In distribution | ||
| 386 Contact 3 E, 04 L | In distribution | ||
| 136 Nipple Set ivory small | 2 | In distribution | |
| 386T Contact 3 E, TW 08 L | In distribution | ||
| 385 Contact light 3S, 02 | In distribution | ||
| 386 Contact 3 E, 05 R | In distribution | ||
| 381 Contact 2S 10 | In distribution | ||
| 286 Balance Contact SV, M | In distribution | ||
| 138 Nipple Set bronze medium | 2 | In distribution | |
| 385 Contact light 3S, 03 | In distribution | ||
| 386 Contact 3 E, 10 L | In distribution | ||
| 383 Contact 2A, 02 R | In distribution | ||
| 383 Contact 2A, 11 R | In distribution | ||
| 334 Adapt Air Contact Light 2SN 03 | In distribution | ||
| 334 Adapt Air Contact Light 2SN 02 | In distribution | ||
| 386T Contact 3 E, TW 01 L | In distribution | ||
| 381 Contact 2S 12 | In distribution | ||
| 386T Contact 3 E, TW 09 R | In distribution | ||
| 380 Contact light 2S 09 | In distribution | ||
| 386 Contact 3 E, 06 L | In distribution | ||
| 229 Balance Contact MD, 05 | In distribution | ||
| 381 Contact 2S 09 | In distribution | ||
| 386T Contact 3 E, TW 11 L | In distribution | ||
| 383 Contact 2A, 10 R | In distribution | ||
| 230 Balance Contact VD, 05/06 | In distribution | ||
| 137 Nipple Set almond small | 2 | In distribution | |
| 381 Contact 2S 04 | In distribution | ||
| 382E Contact 3S EB, 02 | In distribution | ||
| 230E Balance Cont VD EB, 09/10 | In distribution | ||
| 386 Contact 3 E, 02 R | In distribution | ||
| 386T Contact 3 E, TW 13 R | In distribution | ||
| 229 Balance Contact MD, 09 | In distribution | ||
| 229 Balance Contact MD, 08 | In distribution | ||
| 386 Contact 3 E, 03 R | In distribution | ||
| 386 Contact 3 E, 08 R | In distribution | ||
| 386T Contact 3 E, TW 14 L | In distribution | ||
| 386T Contact 3 E, TW 04 R | In distribution | ||
| 334 Adapt Air Contact Light 2SN 08 | In distribution | ||
| 382 Contact 3S 07 | In distribution | ||
| 386T Contact 3 E, TW 10 L | In distribution | ||
| 386T Contact 3 E, TW 06 L | In distribution | ||
| 386 Contact 3 E, 02 L | In distribution | ||
| 382T Contact 3S TW 08 | In distribution | ||
| 382T Contact 3S TW, 09 | In distribution | ||
| 386 Contact 3 E, 11 R | In distribution | ||
| 383 Contact 2A, 06 L | In distribution | ||
| 380 Contact light 2S 07 | In distribution | ||
| 386T Contact 3 E, TW 12 L | In distribution | ||
| 385 Contact light 3S, 06 | In distribution | ||
| 136 Nipple Set ivory medium | 2 | In distribution | |
| 229 Balance Contact MD, 11 | In distribution | ||
| 383 Contact 2A, 05 L | In distribution | ||
| 334 Adapt Air Contact Light 2SN 04 | In distribution | ||
| 230E Balance Cont VD EB, 07/08 | In distribution | ||
| 384C Contact 1S, 02 | In distribution | ||
| 334 Adapt Air Contact Light 2SN 01 | In distribution | ||
| 383 Contact 2A, 07 R | In distribution | ||
| 380 Contact light 2S 04 | In distribution | ||
| 229 Balance Contact MD, 03 | In distribution | ||
| 381 Contact 2S 11 | In distribution | ||
| 383 Contact 2A, 08 L | In distribution | ||
| 382 Contact 3S 09 | In distribution | ||
| 382T Contact 3S TW 04 | In distribution | ||
| 383 Contact 2A, 12 L | In distribution | ||
| 380 Contact light 2S 11 | In distribution | ||
| 382T Contact 3S TW 05 | In distribution | ||
| 386 Contact 3 E, 04 R | In distribution | ||
| 386 Contact 3 E, 09 R | In distribution | ||
| 381 Contact 2S 03 | In distribution | ||
| 383 Contact 2A, 09 R | In distribution | ||
| 383 Contact 2A, 11 L | In distribution | ||
| 230 Balance Contact VD, 03/04 | In distribution | ||
| 384C Contact 1S, 04 | In distribution | ||
| 286 Balance Contact SV, XL | In distribution | ||
| 383 Contact 2A, 04 L | In distribution | ||
| 382E Contact 3S EB, 06 | In distribution | ||
| 386T Contact 3 E, TW 02 L | In distribution | ||
| 383 Contact 2A, 05 R | In distribution | ||
| 384C Contact 1S, 12 | In distribution | ||
| 383 Contact 2A, 04 R | In distribution | ||
| 386T Contact 3 E, TW 07 R | In distribution | ||
| 384C Contact 1S, 08 | In distribution | ||
| 229 Balance Contact MD, 12 | In distribution | ||
| 382T Contact 3S TW, 06 | In distribution | ||
| 380 Contact light 2S 08 | In distribution | ||
| 384C Contact 1S, 07 | In distribution | ||
| 386T Contact 3 E, TW 12 R | In distribution | ||
| 386 Contact 3 E, 09 L | In distribution | ||
| 382 Contact 3S 10 | In distribution | ||
| 230 Balance Contact VD, 09/10 | In distribution | ||
| 230T Balance Cont VD TW, 03/04 | In distribution | ||
| 229 Balance Contact MD, 02 | In distribution | ||
| 380 Contact light 2S 06 | In distribution | ||
| 386 Contact 3 E, 03 L | In distribution | ||
| 229 Balance Contact MD, 06 | In distribution | ||
| 386 Contact 3 E, 07 R | In distribution | ||
| 137 Nipple Set almond meduim | 2 | In distribution | |
| 381 Contact 2S 01 | In distribution | ||
| 384C Contact 1S, 09 | In distribution | ||
| 386T Contact 3 E, TW 14 R | In distribution | ||
| 380 Contact light 2S 03 | In distribution | ||
| 382 Contact 3S 06 | In distribution | ||
| 384C Contact 1S, 05 | In distribution | ||
| 382T Contact 3S TW 02 | In distribution | ||
| 386 Contact 3 E, 01 R | In distribution | ||
| 382E Contact 3S EB, 07 | In distribution | ||
| 384C Contact 1S, 13 | In distribution | ||
| 382T Contact 3S TW 09 | In distribution | ||
| 286 Balance Contact SV, L | In distribution | ||
| 382T Contact 3S TW, 07 | In distribution | ||
| 135 Nipple Set ebony small | 2 | In distribution | |
| 334 Adapt Air Contact Light 2SN 07 | In distribution | ||
| 304 Custom +++ TW | In distribution | ||
| 383 Contact 2A, 03 R | In distribution | ||
| 230T Balance Cont VD TW, 09/10 | In distribution | ||
| 386T Contact 3 E, TW 03 L | In distribution | ||
| 383 Contact 2A, 00 L | In distribution | ||
| 386 Contact 3 E, 14 L | In distribution | ||
| 382T Contact 3S TW, 10 | In distribution | ||
| 382E Contact 3S EB, 05 | In distribution | ||
| 382 Contact 3S 01 | In distribution | ||
| 386 Contact 3 E, 12 L | In distribution | ||
| 385 Contact light 3S, 05 | In distribution | ||
| 334 Adapt Air Contact Light 2SN 09 | In distribution | ||
| 382E Contact 3S EB, 04 | In distribution | ||
| 384C Contact 1S, 01 | In distribution | ||
| 229 Balance Contact MD, 07 | In distribution | ||
| 230T Balance Cont VD TW, 05/06 | In distribution | ||
| 386 Contact 3 E, 06 R | In distribution | ||
| 138 Nipple Set bronze large | 2 | In distribution | |
| 384C Contact 1S, 10 | In distribution | ||
| 385 Contact light 3S, 01 | In distribution | ||
| 386 Contact 3 E, 14 R | In distribution | ||
| 382 Contact 3S 08 | In distribution | ||
| 230E Balance Cont VD EB, 05/06 | In distribution | ||
| 382T Contact 3S TW, 03 | In distribution | ||
| 380 Contact light 2S 13 | In distribution | ||
| 384C Contact 1S, 14 | In distribution | ||
| 382T Contact 3S TW 03 | In distribution | ||
| 230T Balance Cont VD TW, 07/08 | In distribution | ||
| 385 Contact light 3S, 00 | In distribution | ||
| 382 Contact 3S 05 | In distribution | ||
| 382 Contact 3S 03 | In distribution | ||
| 382 Contact 3S 02 | In distribution | ||
| 386 Contact 3 E, 13 R | In distribution | ||
| 382T Contact 3S TW 06 | In distribution | ||
| 382T Contact 3S TW 01 | In distribution | ||
| 386T Contact 3 E, TW 08 R | In distribution | ||
| 382 Contact 3S 04 | In distribution | ||
| 386 Contact 3 E, 11 L | In distribution | ||
| 383 Contact 2A, 01 R | In distribution | ||
| 382E Contact 3S EB, 01 | In distribution | ||
| 386 Contact 3 E, 07 L | In distribution | ||
| 334 Adapt Air Contact Light 2SN 11 | In distribution | ||
| 381 Contact 2S 08 | In distribution | ||
| 386 Contact 3 E, 10 R | In distribution | ||
| 383 Contact 2A, 10 L | In distribution | ||
| 385 Contact light 3S, 10 | In distribution | ||
| 334 Adapt Air Contact Light 2SN 06 | In distribution | ||
| 386 Contact 3 E, 08 L | In distribution | ||
| 381 Contact 2S 02 | In distribution | ||
| 381 Contact 2S 07 | In distribution | ||
| 385 Contact light 3S, 04 | In distribution | ||
| 139 Nipple Set tawny small | 2 | In distribution | |
| 334 Adapt Air Contact Light 2SN 12 | In distribution | ||
| 382E Contact 3S EB, 10 | In distribution | ||
| 230E Balance Cont VD EB, 03/04 | In distribution | ||
| 382T Contact 3S TW, 05 | In distribution | ||
| 135 Nipple Set ebony large | 2 | In distribution | |
| 304 Custom +++ | In distribution | ||
| 229 Balance Contact MD, 04 | In distribution | ||
| 138 Nipple Set bronze small | 2 | In distribution | |
| 385 Contact light 3S, 08 | In distribution | ||
| 380 Contact light 2S 12 | In distribution | ||
| 382T Contact 3S TW, 02 | In distribution | ||
| 380 Contact light 2S 01 | In distribution | ||
| 334 Adapt Air Contact Light 2SN 10 | In distribution | ||
| 383 Contact 2A, 09 L | In distribution | ||
| 386T Contact 3 E, TW 05 L | In distribution | ||
| 380 Contact light 2S 10 | In distribution | ||
| 383 Contact 2A, 07 L | In distribution | ||
| 382E Contact 3S EB, 09 | In distribution | ||
| 385 Contact light 3S, 09 | In distribution | ||
| 334 Adapt Air Contact Light 2SN 05 | In distribution | ||
| 380 Contact light 2S 02 | In distribution | ||
| 382C Contact 3S 00 | In distribution | ||
| 383 Contact 2A, 06 R | In distribution | ||
| 382T Contact 3S TW 10 | In distribution | ||
| 386 Contact 3 E, 13 L | In distribution | ||
| 382T Contact 3S TW 07 | In distribution | ||
| 383 Contact 2A, 01 L | In distribution | ||
| 229 Balance Contact MD, 10 | In distribution | ||
| 384C Contact 1S, 06 | In distribution | ||
| 383 Contact 2A, 00 R | In distribution | ||
| 386T Contact 3 E, TW 03 R | In distribution | ||
| 385 Contact light 3S, 07 | In distribution | ||
| 386 Contact 3 E, 05 L | In distribution | ||
| 386T Contact 3 E, TW 13 L | In distribution | ||
| 383 Contact 2A, 12 R | In distribution | ||
| 380 Contact light 2S 14 | In distribution | ||
| 135 Nipple Set ebony medium | 2 | In distribution | |
| 386T Contact 3 E, TW 10 R | In distribution | ||
| 386T Contact 3 E, TW 07 L | In distribution | ||
| 383 Contact 2A, 08 R | In distribution | ||
| 139 Nipple Set tawny medium | 2 | In distribution | |
| 381 Contact 2S 05 | In distribution | ||
| 382TC Contact 3S TW, 01 | In distribution | ||
| 384C Contact 1S, 03 | In distribution | ||
| 230 Balance Contact VD, 07/08 | In distribution | ||
| 383 Contact 2A, 02 L | In distribution | ||
| 382E Contact 3S EB, 08 | In distribution | ||
| 380 Contact light 2S 05 | In distribution | ||
| 382E Contact 3S EB, 03 | In distribution | ||
| 381 Contact 2S 06 | In distribution | ||
| 137 Nipple Set almond large | 2 | In distribution | |
| 386T Contact 3 E, TW 02 R | In distribution | ||
| 384C Contact 1S, 11 | In distribution | ||
| 382T Contact 3S TW, 08 | In distribution | ||
| 386T Contact 3 E, TW 04 L | In distribution | ||
| 382T Contact 3S TW, 04 | In distribution | ||
| 136 Nipple Set ivory large | 2 | In distribution | |
| 386C Contact 3 E, 01 L | In distribution | ||
| 386T Contact 3 E, TW 09 L | In distribution | ||
| 386 Contact 3 E, 12 R | In distribution | ||
| 386T Contact 3 E, TW 11 R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| StecoTitanmagnetics® | Steco-System-Technik Gmbh & Co. KG | 55 |
| my breast | Natural Breast K.K. | 37 |
| Straumann Extraoral Implant System | Institut Straumann AG | 13 |
| Massage Form® Attach | American Breast Care, L.P. | 12 |
| ABC Nipple | American Breast Care, L.P. | 9 |
| Massage Form® Shaper Attach | American Breast Care, L.P. | 9 |
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.