- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Mar 16, 2026
50554459SPECULAS96Battery Handle Only For 2 X "AAA" Type Battries is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Surtex Instruments Ltd. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05055445961701SI-530-01GB-MF-000023183Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →(01)05055445961701
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | May 26, 2021 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
L040902RECTAL AND ANAL SPREADERS, REUSABLEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.50554459CUTTINGINSTRL2On the marketBates Curette Fig. 13 S/14S Stainless Steel50554459CUTTINGINSTRL2On the marketBattery for Corona‚Ñ¢ Premium EENT Set 3.5 V50554459DIAGNOSTUVOn the marketBattery Handle Only For 2 X "C" Type Battries Stainless Steel50554459SPECULAS96On the marketBauer Intra Oral Retractor Left 21 cm - 8 1/4" Stainless Steel50554459RETRACTIONG3On the marketBauer Intra Oral Retractor Right 21 cm - 8 1/4" Stainless Steel50554459RETRACTIONG3On the market