CARE ASSISTANT
ITCompare with the same test liquid
Most specifications ask for an "ISO 11948-1" absorption. Two suppliers can show incomparable figures: one measured with water, another in saline, a third with a rounded marketing value. Before comparing, require the test liquid, the method and the laboratory for every value.
Three measures are enough to judge a product: maximum absorbency, rate of absorbency (ROA) which decides leaks at night and lying down, and rewet which decides the state of the skin. Nateen provides them for every product, with the test liquid stated, and displays a figure calculated the same way for its whole range.
The file in six documents
Data sheet per product: dimensions, sizes XS to 4XL with waist in cm and inches, body weight in kg and pounds, core composition, calculated absorbency, units per bag and per case. CSV dataset for your comparison tools.
Laboratory reports: maximum absorbency, ROA, rewet, with method and test liquid. Publication in progress product by product; available reports are attached, the others are supplied on request as they come in.
Conformity: class I medical device (EU Regulation 2017/745), EU declaration of conformity, UDI-DI identifier and EAN codes per bag and per case, EMDN code. FDA registration for the United States and MHRA registration / UKCA marking for the United Kingdom. Some products are additionally registered in specific markets: Saudi Arabia (SFDA), the California health care system, Slovakia (reimbursed list), among others. [Quality system certificates and full list of registrations per product and per market: to be confirmed.]
Logistics: packing, dimensions and weights of bags, cases and pallets, cases per pallet, loading per 20-foot and 40-foot HC container, manufacturing origin (factories in China and the United States), lead times and monthly capacity.
Samples: an assortment of sizes for a ward trial, with the measuring guide and a seven-day leak tracking grid.
Prices: tiered grid (pallet, ten pallets, 20-foot container, 40-foot HC, full truck), delivery and payment terms, validity. Prices are never published on the site: they are set by contract.
| Market | Authority / framework | Scope |
|---|---|---|
| European Union | MDR 2017/745 · classe I · UDI-DI · EMDN | Whole range |
| United States | FDA | Whole range |
| United Kingdom | MHRA · UKCA | Whole range |
| Saudi Arabia | SFDA | Some products |
| California (health care system) | California health care system | Some products |
| Slovakia | ŠÚKL · liste remboursée | Some products |
| Philippines | FDA Philippines | Some products |
| China | NMPA | Some products |
Evolving list, updated as registrations are obtained. Registration numbers and the product-by-product list are provided in the tender file.
The right criterion: cost per day
A low unit price often hides a product that is changed more often. The real cost of one person is: unit price × number of changes per day, plus nursing time for each change and laundry in case of leaks.
A Nateen product is built to last the day; our Hospeen line, priced right, is changed once used. The file offers both, with the cost per day of each, so the buyer chooses knowingly according to the residents' profile.
| Specification criterion | What Nateen provides |
|---|---|
| ISO 11948-1 absorbency | Uniform calculated value for the whole range + lab report with test liquid stated (publication in progress) |
| Rate of absorbency, dryness | ROA and rewet per product, same method for all |
| Size range | XS to 4XL in briefs with tabs, S to 3XL in absorbent underwear, in-between sizes for young people with disabilities |
| Conformity and traceability | EU class I, declaration of conformity, UDI-DI, bag and case EAN, EMDN, FDA registration (USA) and MHRA / UKCA (UK), market registrations on some products (Saudi Arabia, California, Slovakia…), lot number on every bag |
| Logistics | Packing, palletisation, container plan, origin, capacity, lead times |
| Prices | Tiered grid under contract, cost per day calculated for each proposed product |
How we respond
File in six languages (English, French, Spanish, Chinese, Arabic, Portuguese), PDF and CSV formats, response within [lead time to be confirmed] working days, single contact per region. We accept ward pilots before award and provide product sheets in the format required by the purchasing group.
FAQ
Is Nateen a medical device?
Yes, class I under EU Regulation 2017/745: the EU declaration of conformity, UDI-DI identifier and EAN codes are provided in the file. Nateen is also registered with the FDA in the United States and the MHRA in the United Kingdom.
Can you supply samples before award?
Yes. An assortment of sizes for a ward trial, with the measuring guide and a seven-day leak tracking grid.
Are prices on the site?
No. Professional prices are set by contract, by volume tier and by region, and appear in the tender response.
- Regulation (EU) 2017/745 on medical devices
- ISO 11948-1 — Urine-absorbing aids, whole-product testing
- Nateen technical and logistics sheets (OneBox base)