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ES-MF-000000153PLASTIC AYRE SPATULA is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Deltalab, S.L.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 11, 2026
84356058UDI-DI-1367Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08435263817270
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
1. Reuse of this product may cause infections. 2. The use of the product does not present any difficulties for the intended users. 3. Not suitable for any application other than its intended use. 4. It should not be used if dirt is observed in the product. 5. Discard the product if any is found to be broken or chipped. 6. It has a sufficient mechanical consistency to ensure the impossibility of breaking during use. Although unlikely, applying excessive pressure during use could break the product. In case of breakage, discard immediately. 7. Due to the intended use of the product, the recipients belong to the healthcare sector and have biowaste containers, where the used product must be disposed of and managed as biowaste. The product, once used, must be decontaminated or treated as contaminated hospital waste. It is the responsibility of each laboratory to handle, treat and dispose of waste according to regulations. Unused products may be considered non-hazardous goods and may be disposed of based on this criterion.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Spain; available across 9 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Jan 1, 1998 | Still on market |
| Cyprus | May 3, 2018 | Still on market |
| Germany | Apr 16, 2015 | Still on market |
| Estonia | Feb 21, 2013 | Still on market |
| EL | Apr 15, 2016 | Still on market |
| France | Feb 14, 2013 | Still on market |
| Latvia | Oct 23, 2013 | Still on market |
| Portugal | Nov 10, 2017 | Still on market |
| Sweden | Mar 29, 2017 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08435263817270Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
84356058UDI-DI-1367440142UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
1 packaging level registered — each level carries its own UDI-DI.
08435263817270× 5 unitsBase unit08435263817287× 500 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
U089002DEVICES FOR GYNAECOLOGICAL CYTOLOGYCertificate health across this manufacturer's portfolio.
2024 PR 0038IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
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