EU Manufacturer
🇲🇾 Malaysia
Active
ITL Asia Pacific Sdn. Bhd.
SRN: MY-MF-000001570
·
Lorong Bemban 2 Plot 17B, 31000 Batu Gajah, Perak, Malaysia
Basic UDI-DIs
110
Total Devices
145
On Market
10
Off Market
135
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
2
Basic Information
- Address
- Lorong Bemban 2 Plot 17B, 31000 Batu Gajah, Perak, Malaysia
- [email protected]
- Phone
- +6053629988
- Website
- www.itlbiomedical.com
Regulatory Overview
Regulation
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Eu Mdd
92
Eu Mdr
10
Eu Ivdr
8
Classification
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Eu Md Class 2b
51
Eu Md Class 2a
41
Eu Md Class 1
10
Eu Ivd Class A
8
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | CL 040404 0057 | TÜV SÜD Product Service GmbH | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 2 countries across Europe.
🇩🇪 Germany
🇫🇷 France
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 15CM RED LINE W/3 WAY STOPCOCK | EU MDD | Eu Md Class 2a | Off Market | 1 |
| 3 WAY STOPCOCK 12 INCH EXT | EU MDD | Eu Md Class 2a | Off Market | 1 |
| 3-WAY STOPCOCK W/15CM TUBING | EU MDD | Eu Md Class 2a | Off Market | 1 |
| 3-WAY STOPCOCK W/30CM LINE RED | EU MDD | Eu Md Class 2a | Off Market | 1 |
| 3-WAY STOPCOCK WITH 24" TUBING | EU MDD | Eu Md Class 2a | Off Market | 1 |
| 4-WAY STOPCOCK W/8CM PRESSURE LINE | EU MDD | Eu Md Class 2a | Off Market | 1 |
| ABDOMINAL PARACENTESIS BAG | EU MDR | Eu Md Class 1 | Not EU | 0 |
| ABDOMINAL PARACENTESIS BAG WITH 40CM LINE | EU MDR | Eu Md Class 1 | Not EU | 0 |
| ARTERIAL KIT | EU MDD | Eu Md Class 2b | Off Market | 1 |
| ARTERIAL PRESSURE MONITORING KIT | EU MDD | Eu Md Class 2b | Off Market | 1 |
| ARTERIAL TRAN/KIT WRIST 180CM ABSS | EU MDD | Eu Md Class 2b | Off Market | 1 |
| Arterial Double Pressure Monitoring Kit | EU MDD | Eu Md Class 2b | Off Market | 1 |
| BLADDER KIT | EU MDR | Eu Md Class 1 | Not EU | 0 |
| CENTRAL LINE KIT | EU MDD | Eu Md Class 2b | Off Market | 1 |
| Catheter Kit | EU MDR | Eu Md Class 1 | Not EU | 0 |
| Catheter Pack | EU MDR | Eu Md Class 1 | Not EU | 0 |
| Catheter Pack | EU MDR | Eu Md Class 1 | Not EU | 0 |
| CrocClampTM Non-Reopening Clamp | EU MDR | Eu Md Class 1 | Not EU | 0 |
| CrocClampTM Non-Reopening Clamp - R | EU MDR | Eu Md Class 1 | On Market | 0 |
| DOUBLE POLE MOUNT PRESSURE MEASUREMENT LINE WITH VEDETTE PLUS TAPS | EU MDD | Eu Md Class 2b | Off Market | 1 |
| DOUBLE POLE MOUNT PRESSURE MEASUREMENT LINE WITH VEDETTE PLUS TAPS | EU MDD | Eu Md Class 2b | Off Market | 1 |
| DOUBLE TRANSDUCER KIT | EU MDD | Eu Md Class 2b | Off Market | 1 |
| DOUBLE/TRIPLE WRIST ART/TRANS CVP 180CM | EU MDD | Eu Md Class 2b | Off Market | 1 |
| Dialysis Kit | EU MDR | Eu Md Class 1 | Not EU | 0 |
| Dialysis Kit | EU MDR | Eu Md Class 1 | Not EU | 0 |
| Dialysis Kit | EU MDR | Eu Md Class 1 | Not EU | 0 |
| Dialysis Kit - OFF | EU MDR | Eu Md Class 1 | Not EU | 0 |
| Dialysis Kit - ON | EU MDR | Eu Md Class 1 | Not EU | 0 |
| DonorCare® Needle Guard Large Channel | EU MDR | Eu Md Class 1 | On Market | 0 |
| DonorCare® Needle Guard Small Channel | EU MDR | Eu Md Class 1 | Not EU | 0 |
| Eye Toilet Dressing Pack | EU MDR | Eu Md Class 1 | Not EU | 0 |
| IBPM DOUBLE POLE DC ART/CVP | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM DOUBLE/TRIPLE POLE DC ART nABSS/CVP | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM DOUBLE/TRIPLE SHOULDER DC ART ABSS/CVP | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Double Pole DC Art /CVP 345cm | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM SINGLE ARM DC ART nABSS | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM SINGLE SHOULDER DC ART ABSS | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM SINGLE SHOULDER DC ART nABSS | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Single 150cm | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Single Arm DC Art nABSS | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Single Pole DC Art 375cm | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Single Pole DC CVP 345cm | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Stopcock 1-Way w/5cm PE Line Clear | EU MDD | Eu Md Class 2a | Off Market | 1 |
| IBPM TRIPLE POLE DC ART nABSS/CVP/PA | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM TRIPLE POLE DC ART/CVP/PA | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Transducer No-Flush | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Triple Pole DC Art /CVP/PA 375cm | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Triple Pole DC Art /CVP/PA 390cm | EU MDD | Eu Md Class 2b | Off Market | 1 |
| IBPM Triple Pole DC Art NRV/CVP/PA 390cm | EU MDD | Eu Md Class 2b | Off Market | 1 |
| INFUSION LINE CLEAR 150CM N/V MEDISIZE | EU MDD | Eu Md Class 2a | Off Market | 1 |